Quality Operations Engineer
Our client a medical device company in Galway are currently recruiting for a Quality Operations Engineer. This role is commutable from Mayo, Clare, Limerick and Westmeath.
Reporting to the Senior Quality Engineer the Quality Operations Engineer will be responsible for driving continuous improvement within the Value Stream, working with the Engineering and Production teams.
- 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.
- 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.
For further information on this Quality Operations Engineer role in Galway please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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