Our client a medical device company in Galway is looking to hire a Staff Supplier Quality Engineer for their site.
The Staff Supplier Quality Engineer is a member of the Supplier Quality Engineering team. They are responsible for Supplier Quality within their prescribed area of functional responsibility. The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.
- Supervision and direction of Supplier Quality personnel (Engineer and Technician grade).
- Lead and drive Supplier QA initiatives within area of functional responsibility.
- Provide supplier quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
- Investigating root cause of supplier issues (SCAR) and ensuring follow-through of timely and effective corrective actions to prevent re-occurrence.
- Strategically lead new material introduction and support new product launches to ensure Supplier Quality meets the required standards.
- Lead and support (as an auditor) various audits of a diverse supplier base.
- Perform on site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues.
- Reporting functional Supplier Quality metrics.
- Preparation of Supplier Quality reports for various meetings and management forums.
- Review Supplier Manufacturing processes. Collaborate with suppliers on process improvement and value enhancement opportunities.
- Facilitate the escalation of unresolved Supplier Quality issues.
- Ownership of the Material Review Board process within the Galway site.
- Lead a team of incoming inspectors ensuring the quality of supplied components meet the company’s requirements.
- Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
- Develop strong links with customer organizations and other project stakeholders.
- Supporting internal and external audits to ISO and FDA requirements.
- Performing an active role in further development and continuous improvement of the quality management system.
- Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.
- Level 8 degree in Science / Engineering or related fields essential.
- Minimum of 7yrs industry experience in a medical device manufacturing environment.
- Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
- Strong CAPA experience.
- Strong root cause analytical and problem solving skills.
- Strong working knowledge of FDA, ISO & MDSAP Quality system regulations for Medical device companies desirable.
- Auditor certification and experience desired.
- Demonstrated excellent organizational skills and ability to work on own initiative essential.
- Supervisory experience desirable.
- Experience in development and coaching.
- Excellent written and verbal communication skills essential.
- Willingness to travel.
For further information on this Staff Supplier Quality Engineer position in Galway please contact Clara Burke on 086 8168273 / email@example.com
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