EU MDR SQ Contract Supervisor – Zuchwil, Switzerla
EU MDR SQ Contract Supervisor - Zuchwil, Switzerland
Jocelyn Blackham is recruiting for a EU MDR SQ Contract Supervisor to join a global medical device company at their site based in Zuchwil on a contract basis for 2 years.
The main purpose of the role will be to:
- To ensure all product technical file contributions meet new EU MDR requirements.
- Provide updated contributions to each workstream supporting aspects of the technical file.
- Lead the EU MDR program for the companies Supplier Quality organization in the (US or EU) and report directly to the EU MDR SQ Program Lead.
- Work with company Workstream leads to develop project goals, deliverables and plans for execution in 2019 inclusive of the following Workstreams: o Packaging & Labeling o Direct Part Marking o Quality Management Systems o Purchase for Resale o MPI Working Group (Manufacturing Process Development) (MDD) o Biological Safety Requirements o Tech File Remediation (PFMEA, PRM, MPI)
Further responsibilities will include:
- Supporting the update of applicable Supplier Quality Procedures and Work Instructions.
- Building, recruiting, and managing a Supplier Quality team to meet all workstream objectives.
- Managing SQ resources to bring Technical Files into compliance with new EU Medical Device Regulations (EU MDR, formerly known as MDD) and re-registering medical devices in the EU (Tech File input consolidation/coordination (PFMEA, PRM, MPI) with workstream inputs.
- Supporting Review and Approval EU MDR Change Projects as applicable.
- Supporting Review and Approval of supplier Process Validation Protocols and Reports as applicable.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor's degree or equivalent in Engineering and/or Technical Field is required.
- Familiarity with ISO-13485 and FDA QSR is required.
- Previous experience in a supervisory capacity is required.
- Background in Supplier Management and Process Validation / Verification.
This is an excellent opportunity to join a leading medical device company.
For more information or to apply for this position, please contact Jocelyn on 0041 (0) 417276793 or email firstname.lastname@example.org. Please quote reference QLS44246 in all correspondence.