A great opportunity for an experienced Engineering professional specialising in Validation and Supplier audits to join an international leader in Medical Devices.
This is an opportunity to play an integral role within a well establsihed site and department that will provide a great platform for future career development.
The Supplier Interface & Validation Engineer will lead as an auditor and a liaison to suppliers over quality issues.
The role is (12:00 - 20:00) but will require routine travel throughout the UK, Europe, Americas and occasional travel to other countries outside the EU.
- Provide outsourcing supplier assurance support for moulding vendors located within the USA.
- Validation strategy and completing validation plans with required change control and
- Statistical analysis of data in process development and validation stage.
- Perform and document supplier audits to regulatory standards
- Maintain approved supplier database and Raise, manage and escalate supplier complaints
- Communicate, negotiate and support customers and suppliers
- Perform investigations into defective parts or materials
- Support the introduction of new material / components to site
- Contribute to the internal audit plan
- Experienced quality professional with a comprehensive knowledge of manufacturing processes
- 3-4 years moulding validation
- Strong audit background, Certified internal auditor
- Has worked in the medical device or pharmaceutical industry
- Needs to be a competent user of Microsoft packages, ideally has SAP and QDMS experience
- Lead Auditor ISO 13485 or CFR 820
- Statistical knowledge, use of Minitab
If this huge opportunity sounds like the one for you then do not hesitate! APPLY NOW!
For questions regarding this role please call James Powell: 02038000509.
Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.
We are dedicated to finding the right opportunity for you.