We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
· Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
· Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
· Conduct benchmarking to develop more effective methods for improving quality
· Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
· Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485.
· Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
· Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
· Lead and maintain Material Review Board.
· Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
· Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
· Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
· Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification
· Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
Education & Experience
· A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
· Experience working in both an FDA and European regulatory environment is preferred.
· This position will require relevant experience working in manufacturing/operations.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or email@example.com for further information.