2 weeks ago

Quality Manager- IVD

Cambridge Competitive Permanent

Job Reference: 176413test

Quality Manager- Biotech

*The company is happy to consider flexible working options*

This is a great opportunity to join a biotech company in Cambridge who are working on cancer diagnostics to help improve and extend cancer patients lives by enabling better targeting of therapies and early detection of treatment.

They are seeking an experienced Quality Manager to build and main a Quality Management System (QMS) to meet ISO 13485 requirements. This role will report into the COO and be responsible for the QMS and Quality Assurance function across the company’s UK and US sites.

Some of the key responsibilities will include:
• Delivering and maintaining a quality management systems for ISO 13485 including all subprocesses
• Promote awareness of applicable regulatory requirements, QMS requirements and customer requirements throughout the organisation
• Developing and delivering training across the company
• Planning, initiating and managing quality improvement projects
• Supporting the product development and software development teams with design control and risk management
• Supporting investigations and compliant handling
• Acting as a point of contact with certification authorities, including arranging and planning for assessments
• Assisting with drafting and compilation of product documentation for regulatory submissions

The company is looking for someone with the following skills/qualifications:
• Previous implementation and maintenance of an ISO 13485 QMS
• Knowledge and demonstrated experience with IVDs and LDTs
• Working knowledge of other standards including 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, and GAMP5
• Excellent leadership skills
• Degree in science/medical or technical field
• Proven industry experience in a regulated environment

If you are interested in finding out more about this role and company, please send your CV to Sabrina Deo at sdeo@pararecruit.com
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