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QA/RA Manager

Job Title: QA/RA Manager
Contract Type: Permanent
Location: Pulborough, England
Industry:
Salary: £37500 - £45000 per annum
Start Date: 2020-01-17
Reference: TS-11
Contact Name: Thomas Southgate
Contact Email: Thomas.Southgate@nesgt.com
Job Published: January 17, 2020 15:28

Job Description

Quality and Regulatory Affairs Manager
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.

The Role:
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
Although the job title is Quality and Regulatory Affairs, this role is bias towards Quality not Regulatory Affairs – and knowledge of Quality is definitely preferable to RA knowledge.

The Candidate:
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.
If you would like to be considered, please don’t hesitate to hit apply to send your CV. Alternatively, please get in touch with Tom @ NES Global Talent to discuss the role in more detail.