We’re currently helping a market-leading Medical Device company to appoint a Quality and Regulatory Affairs Manager to their growing Management Team.
This is a great chance to join a well-known manufacturing organisation in a high-profile role that will offer excellent opportunities for growth and responsibility.
Reporting to the Managing Director, you will take a lead on Quality Management across a busy manufacturing site. You’ll be responsible for ensuring continued compliance with ISO13485 Manufacturing Standards and for managing a team of Quality Assurance Professionals.
More specific responsibilities include:
- Providing Quality and Regulatory Advice to Senior Decision makers on all Quality and Regulatory issues before they affect the business
- Maintaining an Audit-Ready site – ensuring continued compliance to all relevant 3rd party manufacturing legislation
- Supporting quality system design and implementation – including CAPA, Non-Conformance, Change Controls etc.
- Conducting Internal Audits – including advice on Best-Practice and Continuous Improvement
The successful candidate will have an excellent knowledge of Quality Management within the Medical Devices sector. In addition, you’ll have knowledge of:
- ISO 13485 Experience is essential
- Excellent Internal Auditing experience is essential, as is a track-record of success of implementing CAPA Programmes
- Experience and knowledge of document review and validation programmes is essential
- A Higher-Level scientific degree is preferable but not essential – likewise some training in Regulatory Affairs is preferable but not essential.