Supplier Quality Engineer – Medical Devices
||Engineering and Manufacturing
Contact Tracey Bates to talk about this role on 01376 517079
Just Recruitment is recruiting for a Supplier Quality Engineer (Medical Devices) on behalf of a company based in Sudbury, Suffolk.
You will be from a medical device background and have demonstrable auditing experience for ISO 13485.
You will provide quality expertise to help their site in Sudbury, Suffolk meet divisional strategic quality and business goals.
You will elaborate and analyse Quality concepts, methods, tools and procedures as part of an effective Quality Management System. You will also provide Quality Management input to the global Commodity Team and Quality Manufacturing Team, they will co-ordinate supplier corrective actions and supplier development activities in association with the other relevant teams.
We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone in order to grow both personally and professionally.
Key tasks and responsibilities:
- Data collection, production of data, analysis, interpretation and reporting
- SCAR creation and Issue Resolution investigation, administration and monitoring
- Deviation and Non-Conformance administration and monitoring
- Quality document creation, issue, control, review, approval and archive (QCP’s, Procedures, Quality Agreements)
- External Supplier visits and Quality Audits (QMS and Process). Overseas travel required
- Preparing for and hosting suppliers, regulatory and notified body audits
- Representation of Supplier Quality Assurance team at site meetings (Manufacturing, Escalation, SWARM, KT, PST/PHT)
- Quality related improvement projects and quality initiatives
Your experience and skills:
- Significant work experience in quality/engineering role
- Some work experience in the medical device industry or other regulated industry preferred
- Project management skills desirable, but not essential
- Working knowledge of product safety requirements (UL, IEC, ISO, FDA), FEA tools, agile, lean and/or six sigma and statistical techniques is a plus
- It would be beneficial to have electromechanical knowledge
- Good understanding of electro/mechanical principles
- Technical documents
- Must be able to understand technical drawings and documentation