Naynesh Mistry has an exciting opportunity and is recruiting for a experienced Quality individual with working knowledge of Auditing and ISO13485 from the Medical Device industry, to join a leading specialised medical diagnostic company based in Birmingham. Our client engages in the research, development, manufacture, and distribution of immunodiagnostic assays for the laboratory market.
The successful candidate will plan the internal Quality Audit schedule and to monitor our clients key suppliers. The ideal candidate will come with Line management experience with Auditing expertise within the medical device/IVD sector. A trained Auditor would be highly advantageous. This role would suit a candidate with career background as Lead Auditor, Quality/Lead Engineer.
The Role:
- Ensure the Quality Management System (QMS) meets all current Regulatory requirements.
- Management of the internal audit program.
- To manage the relationship with key suppliers and ensure that appropriate documentation is in place to support those relationships.
You:
ESSENTIAL:
- Degree or equivalent in biological sciences or similar.
- Working knowledge of ISO13485.
- Line Management Experience.
- Auditing experience working within a QA or RA environment within an IVD or medical device company.
- Trained auditor.
DESIRABLE:
- Working knowledge of FDA Part 820, 806 and 803.
- Experience of ISO14971 - Risk.
- Recognised Auditing Qualification.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46211 in all correspondence.