Quality Operations Engineer
We’re currently recruiting for an exciting opportunity with an award-winning 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.
• 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.
• Supports new product introduction as part of design transfer.
• Supports activities related to the Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Approve IQ, OQ, PQ, TMV or Software Validation
• Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
Education & Experience
• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 2-4 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 firstname.lastname@example.org for further information.