QA Support - Birmingham

40000.00 - 45000.00 GBP Annual + GBP40000 - GBP45000/annum
04 Jul 2019
31 Jul 2019
Contract Type
Naynesh Mistry has an exciting opportunity and is recruiting for a experienced QA individual with good QMS knowledge from the IVD/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 help create new processes for the SOPs and must possess excellent stakeholder engagement and project management coupled with a strong QMS background. You will also make suggestions as to how the QMS and business processes can be improved and how efficiencies can be made on previous experience and to implement approved changes.

The Role:
- Manage to completion the delivery of projects which have significant Quality Assurance and/or Regulatory impact on requirements.
- To ensure that companywide projects meet all requirements of relevant regulatory standards and Regulations: (ISO9001/13485, FDA 21CFR part 820 and QSRs).

- Degree or equivalent in biological sciences or similar.
- Working knowledge of FDA part 820, ISO13485, cGMP.
- Experience of working within RA/QA environment within an IVD or medical device company.
- Knowledge of Audit, Non-conforming Product and Corrective Action systems.
- Excellent stakeholder management skills.
- Leadership Skills.

- Quality Assurance background.
- Quality Training to ISO9001 and/or ISO13485/21CFR Part 820.
- Currently working in a similar role.

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 45722 in all correspondence