UK QMS Manager - Medical Devices - Interim
Progressive is currently looking for a QMS manager with experience in a regulated industry such as automotive or medical devices.
Principal responsibilities and accountabilities:
- Ensures compliant and effective QMS's are maintained in scope.
- Accountable for the transformation of all current QMS's parts in scope towards the single PQMS structure.
- Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
- Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
- Ensures Q&R requirements are effective in all processes in scope.
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
- QMS non- conformities and CAPA/Non-conformity resolution
- New QMS functionality deployed on time and within budget constraints
- Current system functionality deployed across a large user group leveraging compliance capabilities and improved efficiency.
- Leadership and team performance indicators
- Recognition by business leadership as key resource to the business
- Bachelor Degree in Engineering, quality assurance or biomedical field required
- 2 to 5 years of experience in quality engineering/assurance required
- Deep knowledge in the creation, deployment and support of Quality Systems, Processes and Tools required
- Working knowledge in planning, coordinating and supporting design transfer activities required
- Requires the ability to be hands on and multi task
- Must have experience in a regulated industry (Medical Device, Automotive)
Interested in the role? Give me a call on +31 10 206 9888 or send an email with your resume!