Our Client a medical device company In Galway are currently recruiting for a Senior 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 a customer complaint.
- Leads cost improvement projects and NRE activities within the value stream from a quality perspective.
- Leads 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.
- Leads validation activities within the value stream in conjunction with the validation group including MVP’s, MVR’s, TMV’s, OQ/PQ, PPQ and revalidation assessments.
- Manages 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 and mentoring.
Education, Experience and Skills
- Level 8 degree in Science, Engineering or related subject.
- 5-7 years’ relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
- Significant project management experience.
- Very experienced in new product introductions.
- Excellent knowledge of equipment qualifications, test method validation and process validation.
- Ability to work as a team member and to provide mentorship to other team members.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- A Black Belt qualification would be an advantage.
- Excellent “hands-on” technical skills.
- Excellent communication skills.
For further information on this Senior Project Quality Engineer role in Galway please contact Orla Crowley on 086 0449473/ email@example.com
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