My client, a successful Manufacturing business based in Plymouth is looking for a senior level Quality Manager to join their existing team.
- The successful candidate will participate in the design and manufacturing process to ensure products meet SQCD requirements.
- Will ensure that quality systems procedures, processes, practices and controls are properly developed, implemented and maintained.
- Will take control of product issues and ensure that they are promptly investigated and adequate corrective/preventive action implemented.
- Provide leadership and management of all QA/RA staff
- Resource planning in QA/RA
- Drive regulatory compliance strategies
- Implementation of the Manufacturing Quality Management System (QMS) to meet relevant regulatory requirements
- Reports on the current / ongoing status of the QMS to the MQR
- Manages the QMS improvement processes
- Oversees the Document Change Control process
Qualifications and Experience:
- HND or equivalent in an appropriate scientific or relevant discipline/equivalent experience
- Minimum of five years within a medical device manufacturing facility
- Certified Lead / Principal Auditor Experience in QA or Document Management
- A sound understanding of Quality approaches & techniques relating to the Manufacturing Business
- Experience in an FDA front office inspection environment
- Leadership and Communication skills which can be effective at all organisation levels and across national and cultural boundaries
- An awareness of the Medical Regulatory obligations relating to Manufacturing
- MDSAP awareness
- Minimum of 5 years’ experience in a Quality Management Role
A relocation package is available for this position.
If you are an experienced Quality Manager and you are looking for a new opportunity, please click the "apply" button or call Samantha Edwards for an informal chat. on 01752 252533. Thank you for your interest.