Project Quality Engineer - urgently required for a High volume Medical Devices manufacturing comapny in the Galway area.
- Develop and implement Value Improvement Projects.
- Lead quality-related projects within the value stream e.g. where significant process changes are required that originates from a customer complaint.
- Support cost improvement projects and non re-occurring expense activities e.g. capacity expansions and new product variations within the value stream from a quality perspective.
- Provides Quality support for the transfer of new product into commercial 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 targeted assessments for prevention reviews for new products introduced to the value stream.
- Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- 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 and specifications as required through the change plan process.
- Provides root cause analysis & problem-solving guidance.
What your background should look like:
- Level 8 degree in Science, Engineering or related subject.
- 3+ years relevant Supplier Quality / Quality Operations experience in good manufacturing practice manufacturing environment in Medical Device/Pharma industry.
- Project management experience.
- Green Belt qualification would be an advantage.
- 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.
- Excellent “hands-on” technical skills.
Excellent communication skills.