A Quality Engineer is required by CareerWise Recruitment for our Cork based med device client. This is a 12 month initial contract role. Please contact Diarmuid Buckley for full details.
Role of this position
- 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.
- 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).
- Develop pFMEA documentation to support processes as part of Validation process
- 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.
- 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)
- Ideally -experience working in both an FDA and European regulatory environment iwith an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- Understanding of GMP/ISO and validation regulations.
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)