Senior Quality Engineer NPI Apply
Location: Spiddal, Co. Galway
Time Type: Full time
Posted on: Posted 8 Days Ago
Job Requisition ID: R_00073263
Working at Freudenberg: We will wow your world! Responsibilities: Lead and effectively deliver all quality related aspects of New Product Introduction, ensuring all customer requirements are identified, documented, understood and met. Be part of project teams. Deliver on commits to schedule and budget. Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are always maintained. Ensure processes are validated in accordance with customer and Freudenberg Medical's Quality System requirements. Write validation protocols, reports and test reports as required. Ensure that all customer requirements are identified, clearly documented in Freudenberg Medical's manufacturing documentation and effectively implemented. Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and customer requirements. Lead and investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Freudenberg Medical's CAPA system. Ensure the Quality System is fully compliant with customer and regulatory requirements. Lead the implementation of Structured Problem Solving to drive root cause identification for process and product issues. Drive and implement continuous improvement to processes and product quality. Perform an active role in further development of the quality management system. Supervision, coaching and mentoring of Quality Technicians and Quality Engineers. Work with suppliers and customers on the resolution of product quality issues and quality improvement programs. To take on other duties which the Company may assign you from time to time. Keep your skills current and be conversant with the latest developments which are relevant to the Company's business. Qualifications: Bachelor's degree in Science, Engineering, Manufacturing or related field. Thorough knowledge of medical devices quality systems (ISO13485/FDA). A minimum of five years of relevant progressive experience within a similar role. Experience of New Product Introduction and manufacturing process transfer. Strong Structured Problem Solving and Root Cause Analysis experience (Lean 6 Sigma Green Belt desirable). Strong leadership and people management skills. Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.). Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies. Good interpersonal skills, team player, with a positive attitude in dealing with people. Must be innovative and be driven to implement change to systems and procedures. Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw conclusions. 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.
About Us 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.
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