Working at Freudenberg: We will wow your world! Responsibilities: Provide strategic direction, leadership and expertise in all aspects of Quality and Regulatory Management. Contribute to the achievement of the overall objectives of the company. Ensure effective execution of quality and regulatory organisational strategies and policies. Develop and achieve annual operating plans for the quality function, aligned with the business AOP. Ensure that quality strategies are aligned with the wider Freudenberg Medical organisation. Ensure that an effective and efficient quality management system, appropriate to the activities at the company, is implemented and maintained. Ensure compliance with all relevant quality and regulatory affairs requirements, including ISO13485, FDA, global Freudenberg Medical Quality System requirements and other appropriate standards. Implement appropriate metrics to ensure that the quality system is efficient, effective and utilised in a proactive manner to deliver competitive advantage. To deliver on all budget (AOP) targets within the scope of quality and regulatory systems. Work effectively with others to ensure that the quality function is both supportive and independent. Manage resources and foster cross-functional teamwork to allow for Operational Excellence targets and Policy Deployment goals to be achieved. Ensure that the Quality team has the required capabilities and competencies. Responsible for the professional development of the Quality team. Support the Talent Management process to continuously improve performance and develop personnel skills and behaviors. Accountable for Management Reviews – provide management with objective evaluation of overall quality and regulatory affairs performance and provide guidance for implementation of improvements. Provide leadership to ensure the flawless launch of new products and processes into production. Partner with customers and new product introduction teams in the development and introduction of new products and processes into manufacturing. Ensure that all product and services delivered by the company adhere to the various quality standards expected by our customers and the industry generally. Partner with customers to pro-actively identify and resolve quality issues and ensure products are manufactured in compliance with agreed specifications. Lead the supplier quality program, ensuring best practice supplier quality assurance approaches are implemented. Work with suppliers on quality related issues. Ensure all dealings are professional and good relationships are maintained at all times. Educate all staff members on Quality Systems regulations and the impact of the regulations on their roles and responsibilities to foster ownership and ensure compliance with quality system procedures and regulations. Fulfil the role of management representative for the Quality Management system. Provide leadership to ensure compliance with the requirements of all applicable safety and environmental agencies, including Freudenberg’s Health, Safety, and Environmental Management System (HS&E) requirements. Actively participate in continuous improvement initiatives, initiation, and implementation. Lead quality related projects ensuring that they are delivered on time and within budget. Qualifications: Bachelor’s degree in Science, Engineering, Manufacturing or related field. Thorough knowledge of medical devices quality systems (ISO13485/FDA). Knowledge of LEAN and Six Sigma methodologies is desirable. A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position. Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.). Experience using SAP ERP software and Proficient in Microsoft Office Suite. Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Cambus Teoranta #J-18808-Ljbffr
A leading global technology group in Carrick-on-Shannon is seeking a Regulatory Compliance Engineer. The role involves assisting in regulatory submissions, managing regulatory files, and handling customer complaints. Ideal candidates should be capable of independently resolving issues and ensuring compliance with regulations. This position offers a full-time contract within a diverse and inclusive environment. #J-18808-Ljbffr
Regulatory Compliance Engineer page is loaded## Regulatory Compliance Engineerlocations: Carrick-on-Shannon, Co. Leitrimtime type: Full timeposted on: Posted Todayjob requisition id: R\_00092583**Working at Freudenberg: We will wow your world!**# Responsibilities:Assists in the completion and assembly of regulatory submissions (both international and domestic). Maintains regulatory files including submissions, technical files, etc. Assists in regulatory body, internal & external audits, product recalls, Vigilance and MDR reportability, as necessary. Interfaces with customer service and engineering on customer complaints and complaint investigations. Ensures customer complaints, MDR’s and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards. Assists customer service and quality team in improving the customer complaint process and procedures. Management of domestic and international standards, directives, regulations, etc. for gap analysis according to the latest revision. Independently handle problems that arise within area of responsibility. Able to assist Freudenberg Medical departments in gathering data or special assignments with limited assistance. Performs in-depth review of regulatory data/information and provide oversight of query resolution and database to Supervisor/Manager. Able to change priorities when directed by Supervisor/Manager.# Qualifications:n/aThe Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.VistaMed Ltd.**Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.**Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. #J-18808-Ljbffr
Manufacturing Engineer II page is loaded **Manufacturing Engineer II**locationsSpiddal, Co. Galway time typeFull time posted onPosted Yesterday job requisition idR\_00085222 **Working at Freudenberg: We will wow your world!** **Responsibilities:*** Solution focused, diagnosing and implementing permanent solutions to manufacturing issues in a structured problem-solving approach. Championing problem solving through appropriate documentation and knowledge sharing. * Drive Continuous Improvement by leading the implementation of Lean/Six Sigma manufacturing principles.* Work within a highly regulated environment ensuring highest product quality is achieved through robust quality system processes such as GMP, NCR and CAPA etc.* Improve the production flow to achieve quality at source, rapid feedback from inspections. Ensuring product specification requirements are met and inspection standards are met through concise standard work.* Lead teams in the execution of validation activities.* Analyse and Implement innovative improvements in operational performance through key Overall Equipment Effectiveness (OEE) metrics Yield, Uptime and Performance. Increasing capability, capacity and stability of processes, product, equipment and materials.* Mechanical Design of jigs and fixtures to meet manufacturing requirements, optimise machine changeover time and improve maintenance.* Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact.* Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others. Be aware of the potential environmental impacts associated with your work and the implications of non-conformance. **Qualifications:*** Thorough knowledge/experience of validation techniques & applications (IQ/OQ/PQ, TMVs etc.), associated regulatory requirements and statistical data analysis.* Demonstrate a motivated & flexible approach to work with results-oriented attitude. Excellent interpersonal, communication, planning and organizational skills.* Ability to manage Mid/High level complex technical projects to strict deadlines through appropriate Project Management methods and tools (PMBOK methods).* Influential and motivated team member. Actively promotes and leads cross -functional teamwork environment. Provides technical guidance & mentorship of technicians.* The successful candidate must hold an NFQ Level 8 in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Biomedical) with a minimum of four years relevant industry experience.* Project Management and Six Sigma qualifications will be a distinct advantage.* Problem Solving, Process Improvement, Data Analysis and Project Management experience – Highly Desirable.The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Cambus Teoranta locationsSpiddal, Co. Galway time typeFull time posted onPosted Yesterday **Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.**Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. #J-18808-Ljbffr
**Empowering people, creating technology.****Responsibilities:**This involves but is not limited to:* Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved. * Planning, implementing and co-ordination of New Product Introductions to include: product design, product specifications, process validations identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with VistaMed Procedures and Regulatory standards. * Ensure the requirements of ISO 45001, ISO 14001 and ISO 50001 are considered during design, development and new product introduction and integrated into production processes. * Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of new and existing production. Co-ordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements. * Ensuring effective and comprehensive customer communication throughout the duration of the project. * Planning and co-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with VistaMed Procedures and Regulatory standards. * Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files in accordance with VistaMed procedures and Regulatory Standards. * Development of Manufacturing Process in conjunction with New Product Introduction Team including, as required, training of technicians, process operators and other staff. * Planning and implementing manufacturing cell lay-outs, workstation design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets. * Leading Project management teams to ensure on-time task completion, effective teamwork, good motivation and effective communication. * Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc., either as responsible for timely closure or providing technical support. * Completing any tasks within the project scope including validations, testing, product design and so forth. * Supporting the business acquisition process by way of completing quotations for piece part prices, equipment and other project costs. Providing technical support and customer communication as required. * Completing other tasks as assigned. * Management of PAO/Trainer/Technician/Associate/NPI Engineers, as applicable (Senior NPI Engineer). * Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others. * Be aware of the potential environmental impacts associated with your work and the implications of non-conformance. * Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc). * Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.**Qualifications:*** Third level engineering qualification in Polymer, Biomedical, Mechanical, Design; Minimum Bachelor’s Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent) * Ideally 2-3 years experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing. * **Students** (unqualified) will be assigned to a fully competent individual. Co-signing will be implemented by the student’s Manager. * An **Associate** position may exist where there is limited experience and will be assigned to an experienced Engineer. * Experience in Project Management regarding new product introduction, preferably in a Medical Device environment. * Preferably highly competent in manufacturing processes used for manufacturing catheters etc, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. VistaMed Ltd.**Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.**Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. #J-18808-Ljbffr
Plant Manager page is loaded## Plant Managerlocations: Spiddal, Co. Galwaytime type: Full timeposted on: Posted 10 Days Agojob requisition id: R\_00089767**Working at Freudenberg: We will wow your world!**# Responsibilities:* Develop, manage and achieve annual operating plans for sales, expenses, profitability, inventory and return on net assets.* Direct and execute business strategies with product and market plans to achieve profitable sales growth.* Provide leadership to meet or exceed all plant KPI’s, including KPI’s related to productivity, quality, cost, safety and customer satisfaction.* Provide leadership to meet or exceed customer requirements for quality, cost, on-time delivery, and customer satisfaction.* Instill and maintain a positive team atmosphere.* Manage resources and foster cross-functional teamwork to allow for Operational Excellence targets and Policy Deployment goals to be achieved.* Plan and achieve continuous improvement targets by utilizing Lean Systems and Six Sigma for all operating activities.* Provide leadership to support Division and Company goals and objectives.* Support the Talent Management process to continuously improve performance and develop personnel skills and behaviors.* Manage the operations to meet the requirements any regulatory agencies, as well as the requirements of all applicable safety and environmental agencies, including Freudenberg’s Health, Safety, and Environmental Management System (HS&E) requirements.* Provide leadership to ensure compliance with the Quality System and related standards.* Develop and execute plans for capital expenditures in support of current and future production requirements.* Support development of new technologies to increase productivity and competitiveness.* Provide leadership in a cross-functional team environment to ensure the flawless launch of new products and processes to production.* Keep your skills current and be conversant with the latest developments in Operations Excellence.* Be flexible and take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.# Qualifications:* Bachelor’s degree in Manufacturing, Quality, Engineering or related field desirable.* Masters degree desirable.* Lean operations experience is desirable.The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.Cambus Teoranta**Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.**Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. #J-18808-Ljbffr
Working at Freudenberg: We will wow your world! Responsibilities: Solution focused, diagnosing and implementing permanent solutions to manufacturing issues in a structured problem-solving approach. Championing problem solving through appropriate documentation and knowledge sharing. Drive Continuous Improvement by leading the implementation of Lean/Six Sigma manufacturing principles. Work within a highly regulated environment ensuring highest product quality is achieved through robust quality system processes such as GMP, NCR and CAPA etc. Improve the production flow to achieve quality at source, rapid feedback from inspections. Ensuring product specification requirements are met and inspection standards are met through concise standard work. Lead teams in the execution of validation activities. Analyse and Implement innovative improvements in operational performance through key Overall Equipment Effectiveness (OEE) metrics Yield, Uptime and Performance. Increasing capability, capacity and stability of processes, product, equipment and materials. Mechanical Design of jigs and fixtures to meet manufacturing requirements, optimise machine changeover time and improve maintenance. Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact. Qualifications: Knowledge/experience of validation techniques & applications (IQ/OQ/PQ, TMVs etc.), associated regulatory requirements and statistical data analysis. Demonstrate a motivated & flexible approach to work with results-oriented attitude. Excellent interpersonal, communication, planning and organizational skills. Ability to manage complex technical projects to strict deadlines through appropriate Project Management methods and tools (PMBOK methods). Influential and motivated team member. Actively promotes and leads cross -functional teamwork environment. Provides technical guidance & mentorship of technicians. NFQ Level 8 in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Biomedical) with a minimum of two years relevant industry experience. Project Management and Six Sigma qualifications will be a distinct advantage. Problem Solving, Process Improvement, Data Analysis and Project Management experience – Highly Desirable. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Cambus Teoranta #J-18808-Ljbffr
