Join Our Team as an Associate Quality Manager! As leader of a dedicated Quality Operations team for a site/area, provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Has responsibility for delivering the compliance and business objectives of the function, with primary responsibility to drive engagement and lead the quality team, while ensuring compliance to Stryker Corporate and GQO requirements, Quality System Regulations and standards. Will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which includes, but not limited to the following: Leads Quality Engineering Team to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality. Supports and aligns with the site commitment to ensure the organisation's conformance to producing products meeting or exceeding customer requirements and the relevant regulatory standards. Fosters a positive employee relations environment by promoting open communication, engagement and development of team members. Promotes a culture of inclusiveness, trust, flexibility and teamwork. Create a highly talented team by sourcing, hiring, and placing individuals in positions that play to their strengths and future potential Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards. Participates in ensuring the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits. Ensures effective control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Assesses product & patient risk. Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement. Assist in developing and supports local and global strategies for the Quality Operations function. What You'll Need: Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage. Minimum of 6 years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment. Experience of successfully creating and managing a talented, engaged and performing team is advantageous. Ability to implement organisation and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level) Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies. Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools. Must be able to work in a team & individual environment, interacting effectively at all levels, and across all functions with ability to develop organisational relationship and build trust. Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always. The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. Demonstrated Initiative. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Responsible for manufacturing product in accordance with the relevant Stryker manufacturing procedures and relevant quality standards ? Participation in continuous improvement programmes or team projects to enhance our quality, customer service and cost ? Monitor and verify quality in accordance with workmanship standards and operating procedures. ? Adhere to procedures in relation to production methods, completion of documentation, current Good Manufacturing Practices and safety requirements ? Provide cross training to other employees ? Contribute as part of a team in achieving the line core metrics ? Build Quality into all aspects of their work by maintaining compliance to all quality requirements ? All other duties as assigned. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products. Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. The individual will be responsible for project & stakeholder management and will successfully lead an engineering team to deliver key programmes or projects per associated timelines, quality requirements and budget Your key responsibilities Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyse equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches. Complete capability studies for in process inspection and generate subsequent Inspection documentation. Conduct MSA studies for new products and new processes. Provide training for manufacturing team members. Ensure adherence to GMP and safety procedures. Review and approval of validation documentation. Assume overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling and closure of a project Lead New Product, Process and Technology implementation initiatives while tightly managing project spend on capital & expense budgets Define and clarify project scope while developing and maintaining the project schedule. Ownership for managing and reporting project progress Responsible for identifying, monitoring, and appropriately managing project risk and liaise with broader AO team on common NPI issues and resolutions All other duties as assigned. What are we looking for? B.S in Mechanical Engineering or related engineering discipline with 2 or more years' experience K nowledge of New Product Introduction is desirable Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment. Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment would prove beneficial The individual should enjoy working in a fast paced, dynamic and results orientated team environment. Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Innovative thinker - should be able to envisage new and better ways of doing things. Excellent analytical skills, ability to plan, organise and implement concurrent tasks. Good knowledge of manufacturing processes, materials, product and process design. Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Experience in an FDA regulated or regulated industry beneficial. High level of PC Skills required. Excellent attention to detail. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
A leading medical device manufacturer in Cork is seeking a Manufacturing Operator to build quality products in compliance with strict manufacturing standards. Candidates should hold a Leaving Certificate or equivalent and possess good communication skills. Previous experience in production is advantageous. This role is a 12-month fixed-term contract offering an opportunity to contribute to a team-oriented environment. #J-18808-Ljbffr
A healthcare manufacturing company in Cork seeks a team member for their Production Team. You'll execute manufacturing activities to ensure quality standards and promote operational excellence. Ideal candidates should have mechanical aptitude and good communication skills, with previous production experience as a plus. This role requires flexibility and the ability to work across various processes. Apply today to join a team focused on patient safety and continuous improvement. #J-18808-Ljbffr
Responsibilities Act as a member of the Stryker Ireland Production Team. Execute manufacturing activities in line with Company SOP's and work instructions to ensure that product is manufactured to the desired quality standards in the interest of patient safety. Work in empowered teams which deliver on key business performance metrics. Initiate and participate in projects in order to contribute to continuous improvements. Ensure manufacturing activities are completed in a manner which will not compromise the health and safety of employees and visitors to the Stryker site. Develop, demonstrate and maintain technical proficiency in the relevant manufacturing activities (facilitated through on-site training). In co-ordination with Production Supervisors, plan, schedule and monitor manufacturing activities in the relevant manufacturing cell(s)/team(s). Process product in line with documented Standard Operating Procedures and Work / Process Instructions in a manner which ensures that required standards on EHS, GMP, GDP, Housekeeping (5S Standard) as well as Compliance are proactively maintained at all times. Promote operational excellence and drive continuous improvement in all relevant manufacturing related activities. Liaise with Production Supervisors and other departments regarding application of manufacturing instructions and quality standards. Monitoring of business metrics on EHS, Quality, and Operations in the relevant manufacturing team(s)/ cell(s) to ensure optimum efficiencies/effectiveness against production plans on a shift/daily and weekly basis. Demonstrate proficiency to meet EHS, Quality and Production requirements/targets and take ownership for resolving issues within the cell / team when possible. Escalate issues which cannot be resolved within the Cell/Team. Ensure maintenance activities are completed as scheduled. Demonstrate a flexible willingness to cross-train and operate on multiple, diverse processes / products within the business. Undertake training / development / validation activities and facilitate training for trainees as required to ensure business needs are met. Continually strive to develop and maintain lean manufacturing processes and support implementation of continuous improvements to minimize wastes in all parts of the business. Demonstrate flexibility by transitioning between cells/teams/work shifts as required, in order to meet current and anticipated business needs under the site strategy. Demonstrate acceptable levels of work attendance, punctuality, vacation management and willingness to be available to work overtime as required to meet current and anticipated business needs. Demonstrate competent numerical, literacy, mechanical and spatial skills as required. Role model Company Values and site Ideal Behaviours. Support basic problem solving activities within the cell / area as required. Remain updated on site communications including but not limited to Email, All Employee Meetings and Communication Screens/Boards. Skills and Education Requirements including competencies and skills, required behaviours. Requirements and Experience Must have good verbal reasoning, numerate ability and mechanical aptitude skills. Must have good communication skills, written, verbal, facilitation / presentation. Previous production work experience would be an advantage. Knowledge of GMP requirements would be an advantage. Role model Company Values and site Ideal Behaviours. Technical Skills Basic knowledge and understanding of computer applications. Ensures product quality by inspecting product / documentation and using measuring devices; capable of recording manufacturing data and alerting appropriate people of any deviations from the manufacturing specification where applicable. Ability to understand and safely operate relevant equipment. Reporting and/or correcting unsafe working conditions or practices. CNC Level 2 where applicable (in house training academy). Performing reasonable additional responsibilities as required by Production Supervisors and/or Team/Line Lead. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register. #J-18808-Ljbffr
Permanent Hybrid role based in Carrigtwohill, Cork Position Summary Leads a team as part of the wider post market research and development team to provide product design, packaging design and process support to projects and products. Analyzes engineering drawings and specifications to determine the required type of materials, utility and function based on the product's physical characteristics, safety and special-handling requirements. Key Areas of Responsibility Lead a team to support the successful implementation of new global regulations. Communicate with suppliers, advanced manufacturing engineering and advanced operations to resolve issues and optimize design for manufacturability and efficiency. Will ensure designs are cost efficient, manufacturable and reliable. Lead and contribute significantly in efforts to identify, determine product requirements, generate production drawings for parts and assemblies and develop and manage full product design documentation Lead design portions of projects for design to manufacturing and sterilization. Evaluate and optimize concepts for mechanical function and manufacturability. Develop designs and create prototypes from customer concepts and/or specs to test and validate ideas. Work with advanced quality engineers to develop component specific testing and inspection protocols. Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these target Recruit, select, and on-board top talent. Develop talent within team to increase performance. Actively address performance issues on team. Mentor and provide technical support to reports and colleagues within the broader R&D team. Maintain a high level of team engagement. This position is accountable for achieving packaging design performance and quality objectives, project planning and effective execution, as well as communicating project status and escalating issues when appropriate. Qualifications Knowledge Skills Bachelor of Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Electrical Engineering or Materials Science) with a Minimum of 6 years experience; Master's degree or PhD in an engineering field is desirable. Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams. Open minded- able to recognize good ideas. Innovative thinker - able to envision new and better ways to do things Execute complex problem-solving techniques related to design/technical issues. Independently determines and develops approach to resolving end customers product related issues, through problem solving and troubleshooting product design, and product training. Good instincts and sound judgment for mechanical design. Good understanding of statistical tools and validation/verification techniques. Excellent analytical skills, ability to plan, organize, and implement multiple concurrent tasks. Must be able to analyze and correct complex product and/or process issues and make decisions using independent judgement Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing. Experience with recruiting, people development is desirable. Must be able to generate, follow and explain detailed proposals and operating procedures with an in depth understanding of ISO 13485 and FDA quality system requirements Knowledge of packaging standards highly desirable PC Literate (word processing, spreadsheets, data base) and strong knowledge of project Management tools is essential. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
***23 month fixed term contract*** Position Summary The Senior Automation Engineer will provide advanced technical and engineering support to an automation project(s) or function. This engineer will have the required engineering competencies and systems training to support projects. Key Areas of Responsibility Application of a prioritised approach in Value Centred Engineering toward achieving key opportunities in quality, service and cost. Works with Engineering leaders to deliver business objectives Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem-solving manufacturing issues using Six-Sigma tools. Providing technical leadership on all product, process and Equipment issues. Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP) Transferring and implementing processes, either from development, or from another manufacturing facility. Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team. Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with Stryker New product Development Process. Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation. Conduct Gauge R&R studies for products and new processes. Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate. Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day-to-day operating requirements, and in pursuit of achieving the business targets Fostering a work environment of continuous improvement that supports SYK's Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented. Observing the Quality Management Systems requirements on site at all times Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers Undertaking, where appropriate, a Subject Matter Expert's role for Regulatory Audit purposes Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures. All other duties as assigned. Qualifications Knowledge Skills Level 8 Degree in Mechanical Engineering or equivalent technical experience is required. Proven Project Management skills through the delivery of business-critical projects. Has 2-4 years' experience in a manufacturing environment. Strong communication and influencing skills with both internal and external agents. Capable of technical leading, influencing and providing technical direction to Engineers, Coop Students, Technicians and operators as required. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment Excellent presentation and written / verbal communication skills Demonstrable ability to work autonomously A team player, with a flexible approach. Technological pioneer, willing to source, investigate and implement technological and automation advances Confident and effective decision maker, with a proven leadership ability to negotiate and influence others. #IJ This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Position Summary: Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity. Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. Builds productive internal and external working relationships and may periodically provide guidance and train other team members. Key Areas of Responsibility: Process development and characterisation of various metrology processes (automated / manual) associated with new product launches. Execute Metrology process concepts, process benchmarking, research and process selection. Lead / support capital acquisition activity from specifying equipment, testing, liaising with equipment / component suppliers. Complete RFQ, evaluation, selection and user requirement specifications. Complete Equipment Qualification of Metrology equipment / any other processes as required by the project. Identify and optimise tooling and fixturing for inspection processes. Complete Gage R&Rs, FAIs, process capability studies and inspection program releases in accordance with Stryker new product development procedures. Generate / support generation of PFMEAs, Control Plans, Guidance Documents, applicable process related documentation associated with product launches. Participate in process reviews, lessons learned, print reviews - providing DFM / DFI / DFA feedback. Generate / review / approve validation documentation. Collaborate with production partners to ensure successful transfer of inspection processes and knowledge. Ensure adherence to GMP and safety procedures. All other duties as assigned. Qualifications Knowledge Skills: B.S in Mechanical / Manufacturing / Precision Engineering or related engineering discipline with 2 or more years' industry experience. Passion for Engineering / Process Development / Pushing Boundaries of Technical Excellence. Experience of characterisation of CMMs / vision systems / gauges / other inspection equipment / processes would be advantageous. Read and interpret complex engineering drawings and can understand geometrical dimensioning and tolerancing. Excellent interpersonal skills - must be able to express ideas to the wider cross functional team, collaborate with cross functional teams to achieve project goals, and be open minded with the ability to recognise good ideas. Innovative thinker - should be able to envisage new and better ways of doing things. Continuous improvement and lean 6 sigma mindset advantageous. Experience in executing complex problem solving related to manufacturing / design technical issues. Good instincts and sound judgement for mechanical and structural design. Excellent analytical skills, ability to accurately plan, organise and implement concurrent tasks. Good knowledge of manufacturing processes, inspection equipment, materials and process design. Experience in an FDA regulated or regulated industry beneficial. Excellent attention to detail. This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
23 month fixed term contract Position Summary The Senior Automation Engineer will Provide advanced technical and engineering support to an automation project or function. This engineer will have the required engineering competencies and systems training to support projects. Key Areas of Responsibility Application of a prioritised approach in Value Centred Engineering toward achieving key opportunities in quality, service and cost. Works with Engineering leaders to deliver business objectives Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem-solving manufacturing issues using Six-Sigma tools. Providing technical leadership on all product, process and Equipment issues. Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP) Transferring and implementing processes, either from development, or from another manufacturing facility. Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team. Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with Stryker New product Development Process. Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation. Conduct Gauge R&R studies for products and new processes. Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate. Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day-to-day operating requirements, and in pursuit of achieving the business targets Fostering a work environment of continuous improvement that supports SYK's Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented. Observing the Quality Management Systems requirements on site at all times Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers Undertaking, where appropriate, a Subject Matter Expert's role for Regulatory Audit purposes Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures. All other duties as assigned. Qualifications Knowledge Skills Level 8 Degree in Mechanical Engineering or equivalent technical experience is required. Proven Project Management skills through the delivery of business-critical projects. Has 2-4 years' experience in a manufacturing environment. Strong communication and influencing skills with both internal and external agents. Capable of technical leading, influencing and providing technical direction to Engineers, Coop Students, Technicians and operators as required. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment Excellent presentation and written / verbal communication skills Demonstrable ability to work autonomously A team player, with a flexible approach. Technological pioneer, willing to source, investigate and implement technological and automation advances #IJ This role will be posted for a minimum of 3 days. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
