Quality Projects Engineer required by market leading medical device multinational in Galway to drive continuous improvement within the Value Stream. Experience working in medical device manufacturing is critical.
Responsibilities:
- 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
- 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
Requirements:
- Level 8 Degree in Quality / Science, Engineering or related
- 3+ years supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry
- CAPA experience
- Strong problem-solving skills
- Good working knowledge of validation processes
- Strong leadership skills
- Project management experience advantageous
Please contact Emer Smith to discuss in confidence
00353578638188
emer@emtechrecruitment.ie
