embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. Reporting to the Vice President of Quality, the Sr. Manager of Design Assurance, will lead and build a dynamic medical device design assurance team focused on standardizing and deploying best in class processes that include the design and development of embecta's diabetes care medical device worldwide. This person will lead the engagement and interaction with key internal customers specifically R&D, Quality Systems, Regulatory Affairs, Operations Quality, and Post Market Surveillance teams along with key external leader will drive alignment on quality related processes, targets, and goals. You will be a member of the global quality senior leadership team and support and lead global initiatives and ensure successful outcomes for global quality initiatives and programs. This role is crucial in overseeing and driving sustaining projects for the existing product portfolio and will play a key role in ensuring ongoing product quality and compliance. The primary responsibilities include enhancing design quality assurance processes, spearheading quality engineering and design assurance initiatives, and collaborating with cross-functional teams to foster continuous improvement. RESPONSIBILITIES: The Senior Manager of Design Assurance will be responsible for leading and managing the following activities: Lead the implementation and governance of design control processes in compliance with quality standards such as 21 CFR 820.30, ISO 13485, and ISO 14971. Champion the development and maintenance of risk management files per ISO 14971, ensuring complete traceability from hazard identification to risk mitigation and post-market surveillance. Act as the quality voice in design reviews, ensuring that Critical to Quality attributes are defined, validated, and monitored. Implement Design for Reliability (DfR) and Design for Manufacturability (DfM) principles in collaboration with R&D, Operations and Supply Chain for embecta product. Improve the change control process by streamlining procedures and processes to ensure thorough documentation and communication of changes. Implement quality improvement initiatives. Initiatives should focus on enhancing quality compliance, efficacy and safety of embecta's products by streamlining processes, and reducing process defects or non-conformities. Establish excellent working relationships with quality, R&D, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations. Collaborate with suppliers to ensure the quality of materials and components used in product development. Engenders cooperation between teams to enable issue resolution Serve as a facilitator and mentor to subordinates and fellow co-workers, retain/build organizational talent Successfully mentor and develop the design assurance team by providing training, guidance, and support, fostering a collaborative and innovative work environment People Manager Core Competencies The ideal candidate will develop talent with integrity, transparency, and a focus on measurable outcomes. They will incorporate external perspectives, foster creativity, and collaborate effectively, ensuring inclusivity and continuous improvement. In organizational design and succession planning, they will maintain ethical standards, adapt to industry trends, and engage team members, promoting a culture of inclusivity. Effectively carries out the expectations of People Managers as defined in company's people leadership expectations. Among others this includes maintaining regular, at a minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues and conflict proactively uses judgement in consulting with department leadership and Human Resources. Responsibility for the team's compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team Customer Focus The ideal candidate will prioritize the customer's perspective in strategic decisions, craft service practices that meet customer needs, and continuously seek ways to improve satisfaction. They will encourage experimentation, collaborate with team members, and value diverse customer perspectives. Decision Making The ideal candidate will gather and analyze information ethically, consider external data, and make timely decisions based on clear criteria. They will involve team members and ensure decisions reflect diverse perspectives. Driving Innovation The ideal candidate will inspire ethical innovation, encourage novel solutions, and promote experimentation. They will foster a culture of creativity, collaborate to drive innovation, and ensure inclusivity. Emotional Intelligence Essentials The ideal candidate will establish trusting relationships, accurately interpret emotions, and manage responses effectively. They will continuously improve emotional intelligence skills, build strong relationships, and ensure practices remain inclusive and respectful of diversity. Basic Requirements: Bachelor of Science in Scientific, Technology, Engineering, Mathematics or related discipline. 10+ years of experience in quality engineering or design assurance within the medical device, pharmaceutical, biologics, or related FDA regulated industry. 5+ years in a leadership role with demonstrated progressive responsibility overseeing quality engineering or design assurance teams. Proven track record in leading design assurance initiatives in a medical device company, demonstrating the ability to drive quality improvements and ensure product reliability. Demonstrated ability to implement quality improvement processes and methodologies, such as Six Sigma and Lean, to enhance product quality and operational efficiency. Experience in implementing and optimizing QMS tools (e.g., TrackWise, SAP, PLM systems) to support design control, CAPA, and risk management processes. Hands-on experience with statistical analysis tools and methodologies such as Design of Experiments (DOE), Statistical Process Control (SPC), and Measurement Systems Analysis (MSA). Demonstrated success in leading design assurance activities for medical devices, including design controls, risk management, verification/validation, and product release. Extensive knowledge of FDA and international regulations. Expertise in ISO 13485, and ISO 14971, including other relevant standards for embecta products. Proven experience with risk management and failure mode effects analysis (FMEA), identifying potential risks and implementing strategies to mitigate them. Ability to manage multiple projects simultaneously, including planning, executing, and monitoring project progress to ensure timely and successful completion. This role will have around 10% travel. Preferred Requirements: Master of Science degree preferred. Preferred certifications include Six Sigma, ISO 13485, and ASQ Quality Engineer and/or Certified Quality Manager. Strong leadership skills with experience in mentoring and developing quality teams, fostering a culture of quality and continuous improvement. Expertise in identifying and mitigating risks related to product quality and regulatory compliance. Professional communication and presence. Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management. Competitive base salary based on experience and qualifications: $ (subject to variation depending on physical location). Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate's experience, qualifications, external market conditions, and internal equity considerations. Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for 15% bonus and an annual LTI award. Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. We're looking for a Shift QC Lead to support quality operations on the production floor. You'll lead non-conformance investigations, support lot disposition, and raise Quality Notifications. The role ensures corrective actions are completed and verified for assembly processes. You'll also provide QA support to the Shift Manager as needed. Responsibilities: Managing the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment. Preparation of relevant work sheets and execution of In Process inspection tests Packaging Line clearance verification. Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process. Review In process controls, SOP's, Test Methods and specifications to ensure Lab inspections are being carried out as per design intent. Analysis of data, quality metrics and trends of in-process inspection data. Liaise with relevant personnel regarding flow of product through QC department and other issues that arise. Preparation, review and approval of technical documentation. Perform training as required in the area. Ensure the smooth running of functions under your control. Any other reasonable duties which may be required by Quality management from time to time. Ensure testing equipment is functioning properly and call for repairs where equipment is faulty. Ability to Work in a cross functional team under the supervision of the Senior Quality Engineer. Identify areas for quality control improvement and implement new methods accordingly. Communicate quality or compliance concerns with urgency. Educational Requirements: Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance Relevant Experience: 2 - 3 years' previous experience within similar role. Good knowledge and application ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards. Good experience in the preparation of Technical Documentation. Good knowledge of Statistical Process Control and sampling techniques and standards. Good knowledge of SAP and Trackwise. Good experience in presenting and preparation of supporting documentation for site MRB meetings. A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory). Proven ability of working in a cross-functional team environment. Excellent interpersonal and communication skills. High level of computer literacy. Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. The Quality Engineering Manager - NPI will lead critical projects for new production introduction at embecta Dun Laoghaire by providing leadership to a Quality Engineering Team of 5-7 associates managing validation studies and collaborating with various internal and external stakeholders Responsibilities: Support ISO9000/ISO13485 Quality Systems : Ensuring the company's quality management system aligns with these international standards, which are crucial in the medical devices/pharmaceutical industry. Regulatory Compliance : Ensuring that all activities meet embecta's and external regulatory requirements. Leadership Role : Being a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation. Continuous Improvement : Supporting programs like Six Sigma to enhance processes and product quality. Quality System Management : Overseeing systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis. Customer Interaction : Liaising with key external customers, to ensure that quality standards meet customer expectations. CAPA Management : Ensuring Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards. GMP Oversight : Ensuring Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities. Documentation : Preparing and maintaining documentation to meet regulatory requirements. Education and Experience At least 5 years in an ISO environment, preferably in the medical devices or pharmaceutical industry. 3 + years in a supervisory role, indicating the need for leadership skills Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required. Experience with FDA requirements and audits Experience in process validation, sterilization, and cleanroom environments is a plus. Fixed Term Contract (Fixed Term) embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.comor follow our social channels onLinkedIn,Facebook,InstagramandX. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. This is a hybrid role, and the incumbent will be required to work from our Parsippany, NJ office on Tues/Wed each week. Responsibilities Global Full-Cycle Recruitment: Lead end-to-end recruitment for roles across North America, EMEA, LATAM, and APAC, ensuring a seamless and inclusive candidate experience. Strategic Sourcing: Develop and execute proactive sourcing strategies to attract top talent in diabetes care and adjacent medical device sectors. Business Partnership: Collaborate closely with hiring managers, HRBPs, and functional leaders to understand workforce needs and deliver tailored recruitment solutions aligned with Embecta’s growth strategy. Compliance & Quality: Ensure all recruitment activities adhere to global labor laws, data privacy regulations, etc. Employer Branding: Represent embecta’s mission and values in the talent marketplace, promoting our culture of innovation, inclusion, and patient-centricity. Data-Driven Insights: Track and report on key recruitment metrics to inform decision-making and continuously improve hiring outcomes. Vendor Management: Manage relationships with external search partners and recruitment platforms to ensure quality and cost-effectiveness. Basic Qualifications Bachelor’s degree in Human Resources, Business, Life Sciences, or related field. 8+ years of full-cycle recruiting experience required, with at least 5 years in the medical device or life sciences industry preferred Proven success recruiting across multiple global regions and functions Proficiency with ATS platforms (e.g., Workday) and sourcing tools (e.g., LinkedIn Recruiter, Boolean search) Excellent communication, stakeholder management, and negotiation skills Ability to thrive in a fast-paced, matrixed, and mission-driven organization Must be able to flex schedule to accommodate multiple time zones as needed Preferred Multilingual capabilities (e.g., English + German, French, Mandarin, or Spanish) HR or recruiting certifications (e.g., AIRS, SHRM, PHR) Competitive base salary based on experience and qualifications: $87,600-$118,300 (subject to variation depending on physical location). Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate’s experience, qualifications, external market conditions, and internal equity considerations. Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for an annual bonus. Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page. Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 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embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe. DAY PQS OPERATOR We are excited to announce an opening for a DAY PQS Operator to support our operational needs across the site. This dynamic and varied role is crucial to the success of our daily operations. Main responsibilities will include: The Operator will carry out the full range of responsibilities and duties required to meet current and future operational needs. Operators will carry out all duties assigned by management to include but not limited to product sampling and testing, material reconciliation, quality documentation, Inventory and Stock Management. Operators will need to utilize existing technology effectively and demonstrate a willingness to learn and adopt new tools or equipment as needed. Adhere strictly to Good Manufacturing Practices (GMP) and ensure all activities are compliant with quality standards. Collaborate and communicate effectively with cross-functional teams, including external vendors Operators will participate in initiatives, projects & teams as required including Continuous Improvement, QIP (Quality Improvement Programme), Lean and 6 Sigma type teams. Must have excellent written and verbal communication skills as well as the ability to accurately track and document work performed. Ability to work primarily on your own initiative but experience working as part of a team will be required Requires strong planning, organizational & time management skills to manage the required workload and ensure demands are met Education and Experience A third level qualification in a technical discipline is desirable or Leaving Certificate coupled with substantial experience in a GMP environment. The ideal candidate will have some GMP/GDP experience and high level of safety awareness. 3 + years' work experience in a regulated manufacturing/production environment and have a proven ability and willingness to learn. Experience with ERP systems, MES and SAP is an advantage. Proficient in computer operations with good working knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) Experience of working in a highly automated and high-speed environment and in a controlled clean room environment would be a distinct advantage. You will need to have excellent interpersonal communication skills to interact with colleagues at all levels of the organisation. You will be hands on and have a sense of urgency. Ability to function as part of a team and work on own initiative. Fixed Term Contract (Fixed Term) embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. The Senior Product Engineer will be an integral part of the product lifecycle engineering team responsible for supporting the various product lines in the $1 Billion embecta diabetes business. The Senior Product Engineer's primary role would be to provide support on a global basis for Product Engineering working closely with product development, regulatory affairs, marketing, operations, manufacturing plants, and quality. Responsibilities Utilizing best-in class project management practices, plan and execute product lifecycle engineering R&D projects which impact form/fit/function, business growth, cost reduction and compliance. Lead engineering projects through embecta's change control processes. Communicate project updates and escalations as appropriate to line management and to cross functional stakeholders within the embecta business. Ensure compliance with all local, international and embecta quality and safety regulations, policies, and procedures. Collaborate with manufacturing plants to assist in problem solving and issue resolution. Augment and maintain robust design history files for the current diabetes products and line extensions. Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape and device compatibility. Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements, such as ISO standards. Manage, coach and mentor junior product engineers as appropriate. Education Bachelor's degree in Engineering or Science, preferably in Mechanical, Biomedical, or Chemical Engineering Project Management qualification an advantage 7+ years' experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch. Medical product design, research, and development. High volume manufacturing desired Polymer material science and injection moulding processes. Design verification GD&T 3D CAD modeling. Statistical analysis Test method validation Project management Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. This is a hybrid role, and the incumbent will be required to work from our Dun Laoghaire office on Mon/Tues/Wed (subject to change based on business needs). RESPONSIBILITIES: Global Full-Cycle Recruitment: Lead end-to-end recruitment for roles across North America, EMEA, LATAM, and APAC, ensuring a seamless and inclusive candidate experience. Strategic Sourcing: Develop and execute proactive sourcing strategies to attract top talent in diabetes care and adjacent medical device sectors. Business Partnership: Collaborate closely with hiring managers, HRBPs, and functional leaders to understand workforce needs and deliver tailored recruitment solutions aligned with Embecta's growth strategy. Compliance & Quality: Ensure all recruitment activities adhere to global labor laws, data privacy regulations, etc. Employer Branding: Represent embecta's mission and values in the talent marketplace, promoting our culture of innovation, inclusion, and patient-centricity. Data-Driven Insights: Track and report on key recruitment metrics to inform decision-making and continuously improve hiring outcomes. Vendor Management: Manage relationships with external search partners and recruitment platforms to ensure quality and cost-effectiveness. BASIC QUALIFICATIONS: Bachelor's degree in Human Resources, Business, Life Sciences, or related field. 8+ years of full-cycle recruiting experience required, with at least 5 years in the medical device or life sciences industry preferred Proven success recruiting across multiple global regions and functions Proficiency with ATS platforms (e.g., Workday) and sourcing tools (e.g., LinkedIn Recruiter, Boolean search) Excellent communication, stakeholder management, and negotiation skills Ability to thrive in a fast-paced, matrixed, and mission-driven organization Must be able to flex schedule to accommodate multiple time zones as needed Preferred: Multilingual capabilities (e.g., English + German, French, Mandarin, or Spanish) HR or recruiting certifications (e.g., AIRS, SHRM, PHR) Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. We're looking for a dynamic Engineering Lead to lead a high-performing team in a fast-paced, regulated manufacturing environment. This is your opportunity to shape safety culture, drive process improvements, and champion innovation-all while mentoring talented engineers and ensuring top-tier product quality. If you're passionate about people, precision, and performance, this role is built for you. Responsibilities: Promote a 'Safety First' culture, ensuring that all engineering associates have a forum to discuss safety in positive environment, enabling them to work in a compliant and safe manner. Manage and develop staff in the engineering function through involvement, delegation, and regular reviews of performance as established in both team and individual development goals Develop team capacity through structured training, cross skilling and problem-solving techniques Champion a data-driven, structured problem-solving approach within the Process Engineering team Demonstrate commitment to quality and provide guidance and support to the engineering function, helping associates understand how their role impacts quality Create a culture of compliance, and ensure adequate time and resources are available to enable the engineering team to complete required training within the allocated timeframe Ensure that product quality is maintained to the highest level, and encourage associates to identify product quality issues immediately Lead the Engineering function in delivering on OBI productivity objectives through continuously improving output and waste performance on all processes. Provide technical support and leadership to Operations, Quality and Validation, optimising existing processes as needed to manage and maintain equipment uptime and performance Manage Corrective and Preventive Maintenance, Calibration and Spares Programs Own and have oversight on all engineering Non-conformances, Failure Investigations, Change Management and Customer Complaints. Provide guidance on Failure Investigations. Ensuring all customer focused production requests are met on time and in a compliant manner Provide engineering assessment into customer drawing and design specification changes and manage their introduction. Providing design for manufacture input on component / assembly development projects. Educational Requirements and Relevant Experience: Bachelor's Degree in Engineering. At least 10 years process engineering experience with at least 5 as a people leader within a regulated manufacturing environment. Introduction of new products/technical transfers. Management of high-speed automation projects. Must have the ability to manage concurrent priorities. Project Management experience is advantageous. Must possess good attention to detail and flexibility of approach. Must work well as part of a team. Fixed Term Contract (Fixed Term) embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Join to apply for the Quality Control Shift Lead role at embecta 3 days ago Be among the first 25 applicants Join to apply for the Quality Control Shift Lead role at embecta Get AI-powered advice on this job and more exclusive features. Direct message the job poster from embecta embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. The Role - QC Shift Lead We're looking for a Shift QC Lead to support quality operations on the production floor. You'll lead non-conformance investigations, support lot disposition, and raise Quality Notifications. The role ensures corrective actions are completed and verified for assembly processes. You'll also provide QA support to the Shift Manager as needed. This role is a shift role supporting our 4 Cycle Production schedule. This means 2 days ( 7am-7pm) and then 2 nights (7pm -7am). Responsibilities: Managing the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment. Preparation of relevant work sheets and execution of In Process inspection tests Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process. Review In process controls, SOP’s, Test Methods and specifications to ensure Lab inspections are being carried out as per design intent. Analysis of data, quality metrics and trends of in-process inspection data. Liaise with relevant personnel regarding flow of product through QC department and other issues that arise. Preparation, review and approval of technical documentation. Perform training as required in the area. Ensure the smooth running of functions under your control. Any other reasonable duties which may be required by Quality management from time to time. Ensure testing equipment is functioning properly and call for repairs where equipment is faulty. Ability to Work in a cross functional team under the supervision of the Senior Quality Engineer. Identify areas for quality control improvement and implement new methods accordingly. Communicate quality or compliance concerns with urgency. Educational Requirements: Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance 2 - 3 years’ previous experience in a similar Quality role support production in a busy manufacturing environment. Good knowledge and application ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards. Good experience in the preparation of Technical Documentation. Good knowledge of Statistical Process Control and sampling techniques and standards. Good knowledge of SAP and Trackwise. Good experience in presenting and preparation of supporting documentation for site MRB meetings. A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory). Proven ability of working in a cross-functional team environment. Excellent interpersonal and communication skills. High level of computer literacy. Seniority level Seniority level Associate Employment type Employment type Full-time Job function Industries Medical Device Referrals increase your chances of interviewing at embecta by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles. 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embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. Pen Needle Production Manager The Pen Needle Production Manager oversees all Pen Needle assembly and packaging operations, collaborating with Moulding, Engineering, Maintenance, Automation, Quality, and Supply Chain teams to meet and continuously improve Safety, Quality, Delivery, Cost, and People objectives. Responsibilities: Provide leadership to the Shift Managers and production teams to deliver on SQDCP objectives. Ensure full Health & Safety compliance and engagement across the plant to build a Safety-First culture. Ensure all devices manufactured comply with all Quality and Regulatory requirements Plan Resources to ensure optimum flow of units through the manufacturing process to meet the production schedule. Monitor and optimize stock levels of WIP in the production areas Ensure the production area is compliant with required environmental standards Play a lead role in internal and external audits Develop team members through coaching, delegation, performance reviews and provision of developmental assignments/projects. Collaborate with CI to identify and execute on opportunities to improve work processes and methods to improve efficiency and reduce waste. Lead the weekly BOS process to ensure line productivity and OEE improvements are delivered. Lead and/or support project planning as required Any other reasonable duties which may be required by management from time to time. Educational & Experience Third level degree qualification Manufacturing/Engineering/Science coupled with appropriate experience in high volume manufacturing. 5 + years in a production supervisory/management role in manufacturing. Thorough knowledge of production management principles Preferably a minimum of 5 years' experience in a regulated manufacturing environment Excellent documentation skills and attention to detail Knowledge of budgetary control procedures. The ability to lead, work as part of a team and on own initiative as required Proactive - someone who anticipates potential problems and is a step ahead Working knowledge of engineering and improvement concepts associated with a high volume, technically complex, regulated manufacturing unit. Excellent interpersonal and communication skills Good PC skills Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
