As part of the company’s ongoing expansion plans, we are now looking to appoint a fulltime Quality Manager to be responsible for leading and supporting all staff in adhering to the requirements of the Quality Management System. Reporting to the Chief Operating Officer, the Quality Manager will also drive the continuous improvement activities within the business and in addition will be the key contact for regulatory and compliance matters with customers.
Depending on the experience of the candidate, they may also be given responsibility for the Health & Safety and Environmental Management System.
- Own and manage the Quality Management System. This includes ensuring:
- Compliance to the QMS across the company.
- Successful outcomes for any audits.
- Implementation of additional standards as required e.g. ISO13485.
- Liaising with customers and collaborators on regulatory and compliance matters for diagnostics and therapeutics projects.
- Drive the process of Continuous Improvement in the business, including being the Six Sigma Champion.
- Own and manage the Health & Safety and Environmental Management System (subject to experience).
- Develop and maintain Quality metrics and KPIs and use these to drive improvements in Quality systems and processes.
- Create, agree and implement the Quality part of the company business plan and also support other senior managers in their parts of the plan as necessary.
- Delivery of training and awareness to the business for areas of process improvement, and compliance to Quality requirements.
- Advise the senior management team and the Board on Quality related matters which may be of relevance either immediately or in the future.
- Contribute to the wider strategic development of the company and the formation of policy and strategy.
Desired Skills & Experience
- Ideally 5+ years’ experience as Quality Manager in a biotechnology or medical device company with extensive experience of ISO9001/ISO13485.
- Minimum of BSc honours level degree in Chemistry, Biology or Biochemistry.
- Six Sigma Green Belt (Black belt preferred).
- Proven track record of Continuous Improvement.
- Team player with a can-do attitude.
- Experience of managing Health & Safety/Environmental Systems would be an advantage.
Please apply using the apply button with a copy of your CV and a covering letter.