A Staff Supplier Quality Engineer is required by CareerWise Recruitment for our Galway based client. 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. Please contact Tom Devaney for more information.
Role of this position
- 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 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.
- Level 8 Degree in Science / Engineering or related fields essential.
- Minimum of 7 years 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.
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)