Supplier Quality Manager

MEDICAL DEVICES
MEDICAL DEVICES
Galway
Permanent
15756
Galway
Permanent
15756
Overview:

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.

 

Key Duties

·       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

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Elaine Dolan
Senior Recruitment Consultant