An innovative medical supplies company using advanced technology has a new opportunity for a Quality Assurance Manager. This is a standalone role but you will be working closely with the Engineering Director and with colleagues across the business to implement new quality assurance and control processes to drive compliance and certification within the company.
Specific responsibilities include:
- Initiating and leading a programme towards ISO9001 & ISO13485 accreditation
- Working with the design & development team to ensure CE/UL mark certification
- Creating, developing, and continually improving the process and ensuring alignment within the production team
- Developing and delivering all ISO required audits
- Acting as the POC and responsible authority for all registered products
- Working with the production team and design engineers to improve and maintain quality and safety standards
- Managing the non-conformance reporting
- Working with engineers to set the appropriate specification and tolerances for individual parts
- Working closely with sales and technical support regarding customer care
- Designing and implementing quality processes across production including setting the standards for documentation
- Setting manufacturing quality metrics and KPIs
About you:
- Quality Assurance and regulatory experience essential
- ISO9001 accreditation experience essential (ISO13485 desirable)
- Background in medical sector would be ideal
- Knowledge of manufacturing or engineering sector advantageous
- Strong understanding of Lean Six Sigma and problem-solving methodologies
- Ability to work with a variety of internal stakeholders essential
This is a great opportunity to work within a cutting edge medical start-up at a time of growth. Own transport is needed to get to the office.
Flexibility: 3 days per week, hybrid, 1 day in office
Location: Surrey and home
Pay: £45,000 - £50,000 FTE
Account Manager: Jayne Winch