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.
• Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
• Support Quality and Validation activities for product transfers and new product introductions.
• Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
• Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
• Determine process inputs and factors for variation where process capability is required.
• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
• Develop pFMEA documentation to support processes as part of Validation process
• Partner with R&D and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
• Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
• Support root cause analysis activities related to material processes.
• Communicate effectively with global functions and internal team on actions and deliverables.
• Provide timely and accurate reporting and management of escalations as appropriate on project activities.
• Ensure all activities comply with GMP, ISO and quality system requirements.
• Ensure that all health, safety and environmental requirements are fulfilled.
Education & Experience
• BSc in Engineering or Science with 2 years’ experience in a medium to high volume manufacturing environment
• 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
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.