Senior Projects Quality Engineer
Senior Projects Quality Engineer - Galway - Medical Device
- Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- Lead quality-related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or a customer complaint.
- Lead cost improvement projects and NRE activities within the value stream from a quality perspective.
- Lead quality support for the transfer of new products into device manufacturing.
- Provide additional support to the operations team when a new product is introduced to the value stream where required until the product has reached a steady state.
- Completion of TAP analysis for new products introduced to the value stream.
- Lead validation activities within the value stream in conjunction with the validation group including MVPs, MVR’s, TMV’s, OQ/PQ, PPQ, and revalidation assessments.
- Manage the approval of supplier change notifications.
- Support audits for the value stream from external regulatory agencies and customers and lead preparation activities in advance of such audits.
- Update quality procedures, specs as required through the change plan process.
- Provide root cause analysis & problem-solving guidance and mentoring
Qualifications & Requirements needed
- Level 8 degree in Science, Engineering, or a related subject.
- 5-7 years’ relevant supplier quality/quality operations experience in a GMP manufacturing environment in Significant project management experience.
- Very experienced in new product introductions.
- Excellent knowledge of equipment qualifications, test method validation, and process validation.
- A Black Belt qualification would be an advantage.
- Excellent “hands-on” technical skills.
Excellent package on offer such as Full Healthcare, Pension & Bonus
Please contact Elaine Dolan for more information on email@example.com