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 Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes.
• Prepare several documents as part of the IQ, OQ, PQ processes.
• Support colleagues to complete several tasks
• Responsible for ensuring design of machine is aligned with operations needs, quality, EHS, validation, quality automation, maintenance requirements.
• Validate the machine as per the specifications, procedures, regulations
• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s of assets and associated machines.
• Develop pFMEA documentation to support processes as part of Validation process
• Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
• Communicate effectively with project manager and other managers, global functions and internal team on status of project(s) tasks, issues and requirements.
• 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.
Education & Experience
• BSc in Engineering or Science with 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.
• Problem solving engineering expertise (Six Sigma, SE or A3)
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.