Quality Manager ISO15189

40000.00 - 60000.00 GBP Annual
22 Feb 2021
22 Mar 2021
Contract Type
Full Time
Quality Manager ISO15189

Salary GBP40k-60k DOE

A brilliant and exciting opportunity to join a rapidly growing company based in Birmingham. The company develop, manufacture and sell products to research institutions and hospitals involved in cancer research and prenatal medicine. As a result of continued strong growth, there is the need to add to the Quality Management team and somebody experienced with ISO15189.

* To assist with accelerating the business plans for manufacturing and future CE-IVD marking of products.

* The inspection of technical information for CE-IVD marking submission; ensure continued ISO15189 certification and compliance with European Regulation

* Assist with all and any aspects of ISO15189 accreditation, including assessing gaps to accreditation standard and creating/implementing a plan to fill these in conjunction with the technical teams.

* Managing the company's electronic quality management system for ISO15189 including third party external audits, such as preparation of relevant QMS documents (QM, processes, work instructions, forms etc.).

* Implement and maintain the regulatory documentation across a wide portfolio of devices to ensure that company products are safe, legal and are compliant with European regulations.

* Work closely with the Technical teams and management to ensure timely delivery of quality goals.

* Ensure compliance with all Health & Safety / Environmental and Welfare requirements.

Minimum Qualifications/Experience

* Quality Management experience within the Medical device industry or within a certified medical laboratory.

* A demonstrable strong working knowledge and experience of applying ISO15189

* Possession of a degree or equivalent in a Biological Science or Chemistry.

Preferred Skills/Experience

* Proven track record of delivering CE-IVD products into the market.

* Excellent attention to detail.

* Ability to plan multiple tasks and effectively prioritize activities.

* Capability to drive assignments to completion.

* Effective communicator with management, peers and internal customers.

* Pro-active with proven ability to work under own initiative.

* A strong team player