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.
Experience & Education
• 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)
• Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
• A thorough understanding of GMP/ISO and validation regulations.
• Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Problem solving engineering expertise (Six Sigma, SE or A3)
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred