Quality Manager - Cambridge - £60-65k Salary
TEC Partners are working with an exciting biotech company, who are looking for an experienced Quality Manager to join their team and push for ISO13485 accreditation in the next couple of years. You will also have the opportunity to build a small team around you, whilst also remaining hands-on implementing Quality across the business.
This role is based in the Cambridge area and is well suited to a Quality Manager with experience in; Medical Devices, Biotech or Pharma. Whilst this role is grounded in quality, it is expected that the successful Quality Manager gets involved across the business as they expand.
Quality Manager Responsibilities:
To drive implementation of ISO13485
Promote and drive internal awareness and knowledge of quality and regulatory standards, while ensuring compliance to the internal quality system, and providing suitable interpretation to the company
Effective monitoring, maintenance and improvement of the quality management system and quality risk management through trends and statistical analysis.
Monitor and analysis of quality KPI's, deviations, non-conforming product, complaints, change management and CAPA processes to identify trends through statistical analysis
Serve as the management representative, liaising with the notified body prior, during and post annual audit
Develop and implement plan for audits both internally and supplier
Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required
Aid introduction of an electronic quality system
Mentor and develop a culture which includes honesty, transparency and openness and teamwork
Maintain safe working practices in facilities in accordance with current HSE (UK) regulations and guidelines in the laboratories
Quality Manager Candidate Profile:
Proven Quality Management with 5+ years' experience in; Medical Devices, Pharma or Biotechnology
Experience implementing ISO:13485
Prior experience using an Electronic QMS
Track record of being flexible in a fast-pace, demanding environment
Competent in problem solving, team building, planning and decision-making.
Leadership experience in a similar environment
Excellent attention to detail and organisational skills
Able to prepare technical reports, papers, presentations and Lab SOP's
This Quality Manager role is a truly unique opportunity and they are in a great moment of expansion, so don't hesitate to apply immedaitely
Complex Problem Solving