Do you have a passion for Quality and a background within regulated Medical Device, Pharmaceutical or other Healthcare environments, regulated to ISO or GMP standards? If so, this is a fantastic opportunity with a highly reputed medical device organisation near to Gatwick, West Sussex.
This is a permanent role for a Quality and Regulatory Manager. Reporting to the MD, you will lead, mentor and grow two closely related teams and will have a range of duties to provide Quality and Compliance support to all departments and drive continuous improvement. You will be physically situated near to the shop floor in a highly regulated, modern production facility, so this role will suit someone who enjoys getting stuck into a range of projects, overseeing QA / RA strategy whilst also building relationships within a busy, ambitious business. We are looking for an adaptable, energetic, collaborative, honest and versatile person to join a pioneering company that has a significant market share in the UK, Europe and elsewhere, for its products which make a genuine difference to patients’ lives.
This is a permanent position, paying a very generous salary (to discuss on application), pension, life insurance and 25 days’ holiday. The company has thrived throughout Covid and has put some good measures in place to preserve social distancing, so your role will be on site. The company is near to Gatwick and Crawley in West Sussex.
Your role will be:
- To lead the QA and RA functions in implementing and maintaining systems to the highest standard, driving Continuous Improvement and maintaining compliance to ISO 13485, ISO 14971, MDD and MDR. across all areas of the business.
- To be responsible for CE and UKCA marking of Class 1 and Class 1a medical devices.
- To act as the person responsible for Regulatory Compliance (PRRC) as defined in Article 15 of MDR EU/2017/745 and as Management Representative as defined in ISO13485.
Your duties will include:
- Promoting continuous improvement within the company and supporting the development of LEAN and Six Sigma
- Driving improvements across the business, including supply chain and distribution functions, to maintain and improve product quality and process efficiency
- Maintaining technical documentation to support CE and UKCA marking, and partnering with distributors worldwide to maintain compliance to local regulations
- Leading bright and hard-working teams (currently 3 in Regulatory Affairs, and the QA Manufacturing Manager who in turn leads a team of Quality Engineers)
- Developing, implementing and maintaining Quality Management System processes and procedures including CAPA, risk management, non-conformances, change control and validation to ensure compliance with internal standards and relevant regulatory requirements.
- Hosting customer audits and leading regulatory site inspections.
- Approving suppliers and maintaining strong collaboration with external parties.
- Supporting development of personnel by providing relevant training, tools, skills and motivation to provide opportunities for personal improvement and encourage contribution towards continual improvement.
Skills and Experience Required:
- Strong experience of Quality Assurance gained within a commercial Medical Device or Pharmaceutical setting, regulated to ISO standards (specifically, ISO 13485, ISO 14001, ISO14971, ISO10993, ISO11137) or GMP
- Candidates will be considered from outside the Medical Device industry, if you can demonstrate strong experience in GMP and transferable skills
- You will ideally be a certified Lead Auditor, with significant experience of leading internal audits and hosting external inspections
- Lean six sigma background is desirable, ideally with a black or green belt
- Understanding of Continuous Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM.
- Excellent leadership and communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role near to Gatwick and Crawley, West Sussex.