EU MDR Supplier Quality Contract Supervisor
Jocelyn Blackham is recruiting for an EU MDR Supplier Quality Contract Supervisor to join a Global Medical Device company based in Zuchwil in the Canton of Solothurn on a contract basis for 12 months, with the possibility of extension.
The main purpose of the role will be to:
- Ensure all product technical file contributions meet new EU MDR requirements.
- Develop project goals, deliverables and plans for execution in 2019 inclusive of the following: Packaging & Labeling / Direct Part Marking / Quality Management Systems / Purchase for Resale / MPI Working Group (Manufacturing Process Development) (MDD) / Biological Safety Requirements / Tech File Remediation (PFMEA, PRM, MPI)
- Reference EU MDR for Key deliverables.
- Liaise with company leads to shape project goals, deliverables and plans for execution in 2019 and build, recruit and manage an SQ team in the (US or EU) to meet all objectives
- Build, recruit, and manage a Supplier Quality team to meet
- Manage Supplier Quality resources to bring Technical Files into compliance with new EU Medical Device Regulations and re-registering medical devices in the EU (Tech File input consolidation/coordination (PFMEA, PRM, MPI).
Further responsibilities will include:
- Working with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
- Supporting Review and Approval EU MDR Change Projects as applicable.
- Supporting the update of supplier related Inspection Criteria as applicable.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A minimum of a Bachelor's degree or equivalent in Engineering and/or Technical Field is required (or equivalent).
- Familiarity with ISO-13485 and FDA QSR is required. Excellent organizational skills and attention to detail is required.
- Experience in a supervisory capacity is required.
- Background in Supplier Management and Process Validation / Verification.
- Process Excellence Black Belt or Master Black Belt is desired.
- Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
This is an excellent opportunity to join a global Medical Device company.
For more information or to apply for this position, please contact Jocelyn Blackham on +41 (0) 417276793 or email jblackham@ckqls.ch. Please quote reference QLS43488 in all correspondence.