Senior Supplier Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Supplier Quality Engineer for their site.
- The Senior Supplier Quality Engineer is a member of the Operations Quality group.
- S/he is 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.
- 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.
- 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.
- Degree in Science / Engineering or related fields essential.
- Minimum of 5yrs 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 and ISO Quality systems 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
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