Our Client a medical device company in Galway are currently recruiting for a Project Quality Engineer.
- Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- Leads quality related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or customer complaint.
- Supports CIP and NRE activities within the value stream from a quality perspective.
- Provides quality support for the transfer of new product into device manufacturing.
- Provides additional support to the operations team when a new product is introduced to the value stream where required until the product has reached steady state.
- Completion of TAP analysis for new products introduced to the value stream.
- Supports validation activities within the value stream including MVP’s, MVR’s, TMV’s, OQ/PQ, PPQ and revalidation assessments.
- Supports the approval of supplier change notifications.
- Supports audits for the value stream from external regulatory agencies and customers and leads preparation activities in advance of such audits.
- Updates quality procedures, specs as required through the change plan process.
- Provides root cause analysis & problem-solving guidance.
The Ideal Candidate
- Level 8 degree in Science, Engineering or related subject.
- 5+ years relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
- Project management experience.
- Good working knowledge of validation processes.
- Ability to work as a team member.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- A Green Belt qualification would be an advantage.
- Excellent “hands-on” technical skills.
- Excellent communication skills.
For further information on this Project Quality Engineer role in Galway please contact Orla Crowley on 086 0449473/ email@example.com
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