Supplier Quality Manager
Supplier Quality Manager - global Medical Device organisation - Galway - permanent role
The Supplier Quality Manager 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 company 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. Minimum of 5 direct reports.
· Supervision and direction of Supplier Quality personnel (Engineer and Technician grade).
· Lead and drive Supplier QA initiatives within the area of functional responsibility.
· Provide supplier quality input and support to the Manufacturing, Engineering, Prototype, and Commercial functions.
· Investigating the root cause of supplier issues (SCAR) and ensuring follow-through of timely and effective corrective actions to prevent re-occurrence.
· Strategically lead the 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
· Lead a team of incoming inspectors ensuring the quality of supplied components meets the company’s requirements.
· Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
· 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.
Key Requirements needed
· Level 8 degree in Science / Engineering or related fields essential.
· Minimum of 7yrs industry experience in a medical device manufacturing environment.
· People management experience essential. A clear understanding of 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.
Benefits include; full family healthcare, pension, annual bonus
For more information, or a confidential discussion please contact Elaine Dolan on 091 706 718