Cambridge Life Sciences is a well-established clinical chemistry company based in Ely near Cambridge. We produce clinical diagnostics tests that are used for medical and research purposes, globally. We are part of a dynamic and fast-moving group. Following its acquisition in 2021, the company is now gearing up for significant expansion and growth into new fields of expertise within medical diagnostics.
We are seeking an experienced Quality Manager who will be responsible for the compliance to IVDR and establishing CE and UKCA marks and the maintenance of our quality management system to meet ISO 13485 & ISO 15189 requirements and Quality Control of the production site. The role will see you responsible for two sites, harmonising the Quality Management System across both locations and driving continuous improvement within the quality culture. As Group Quality Manager you will need to be able to juggle managing a team of three whilst also remaining hands on in the day to day quality activities such as:
Key Responsibilities:
- Ensure department targets and objectives are met, including post-marketing vigilance, quality, complaint analysis, product conformances
- Planning, initiating, and managing quality improvement projects
- Conducting internal and external audits
- Approval of technical transfers and Quality Agreements Audit contractors and suppliers etc. to ensure they comply with site standards
- Provide advice and support to sales/ technical personnel and other stakeholders
- Monitor quality data daily, and take appropriate action, make decisions, or highlight when necessary
- Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance by developing key supplier partnerships
- Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence
- Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards
- Any other duty assigned within the skill of the employee
Essential Criteria:
- Bachelor’s degree in Quality / Science / Engineering or other Technical field
- Manufacturing and distribution experience working in a quality assurance role or related department desired
- People/quality management experience
- Must have an understanding of common problem-solving tools
- Experience in Lean Six Sigma with certification required
- Audit qualification or experience
- Prior experience maintaining a QMS aligned with ISO 13485 and, ideally ISO 15189 (or ISO 9001, ISO 17025)
- Previous experience in attaining CE / UKCA marking Preparation experience for external audit by regulatory bodies (BSI, UKAS or similar agency)
Desirable:
- Strong leadership and change management skills Candidates from a Medical Device background with FDA/ISO or having substantial experience with ISO 9001/13485 will have an advantage
- Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions.
- Proficient at multitasking and prioritizing
- Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products
To apply please email your CV and covering letter, highlighting why are suitable for this role, to HR@clsdiagnostics.com