1 month ago

Director of Quality - Cambridge

Cambridge Competitive Permanent

Job Reference: CB-DIRECTOROFQMS_1634566708

Director of Quality Assurance and Compliance - Cambridge

Rapidly growing international biotech company in Cambridge are seeking someone experienced in Quality Management to take charge of their quality management system.

This company are looking for an experienced motivated individual to assist them in their mission to extend cancer patients lives through the development of precision cancer diagnostics. This company plans to double in size by the end of the year and thus are seeking someone who has the knowledge and expertise in Quality Assurance and Compliance to help them get there.

The main responsibility of this director position is building and maintaining a Quality Management System to meet ISO 13485 requirements. You will be reporting to the Chief Operating Officer and be responsible for the Quality Management System and Quality Assurance function across both their US and UK sites.

Main Responsibilities;

Delivering and maintaining a quality management system for ISO 13485
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 complaint handling
Ensuring supplier and subcontractor compliance
Acting as a point of contact with certification authorities, including arranging and planning for assessments
Assisting with drafting of product documentation for regulatory submissions

Ideally you will have;

A degree in science, medical or technical field
Proven industry experience in a regulated environment e.g. ISO 13485, ISO 15189, or ISO 17025
 Knowledge and demonstrated experience with LDTs and IVDs
Excellent organisational, communication and leadership skills
Working knowledge of other applicable standards including 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, and GAMP5
A hands-on approach with a fantastic attention to detail

This is an amazing opportunity to join this international start up company and have a huge impact on the company and their Quality Management System. In return they are offering a very competitive salary, private medical insurance, private pension and share options.

If you would like to apply or hear more about this opportunity please do not hesitate to contact me either via email cbeasley@pararecruit.com or phone 01216163466.

Furthermore, if you are interested in hearing about other roles within the Bioinformatics and Genomics industry please feel free to contact me for a confidential discussion.

Keywords; QMS, Quality Management System, ISO 13485, Regulated Environment, Biotech, Biotechnology, Quality assurance, QA, QC, Quality compliance, Medical devices, IVD, Leadership, Manager, Director, Team Lead, Team Leader, Cambridge,

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. By applying for this position you agree to our privacy policy which can be found here: https://www.pararecruit.com/legal/privacy-policy/
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