Head of Quality Assurance – Medical Device

Salary: £36,000 – £43,200 per year

Do you have a strong QA Management background from the medical device industry? Do you have a good understanding of the EU – MDR regulation and the requirement for the transition? If so, this is a great opportunity for an experienced leader to join a fast – growing medical device company who is working on global projects across all device ranges.

We are looking for a Head of Quality as this is a newly created role to help the team to make the transition to EU – MDR and prepare for the upcoming audit. You ultimately will be responsible for 3 departments: quality, complaints and servicing. You will need to attend on site 2 days a week and work from home for the rest of the time. The role is directly report to the Technical Director and there is opportunity to progress into Director of Quality.

This a permanent role with a highly competitive salary. The role requires someone who can be flexible and hands on as it will involve reviewing documents and organising QMS updates and reviewing remedial actions.

Your role will include:

• To provide accurate and current quality management advice to the technical team.
• Ultimate responsibility for ISO13485 QMS maintenance and accreditation.
• Responsibility for ISO14001 QMS maintenance and accreditation and for the change management process.
• Ultimately responsibility for the servicing department and for 13485 QMS procedures.
• Perform/conduct quality meetings, audits, or other relevant quality requirements.
• Management of preparation and coordination of annual regulatory/quality system audits both internal and external.
• Manage and supervise all quality department team members.
• Provide expert quality inputs on New Product Development.
• Provide approvals for change control, product specifications and other medical device quality documentation as required.
• Liaise with and manage external consultancy’s as required.
• To assist as required by the Quality Assurance/Complaints Officer with any regulatory related technical investigations into customer product complaints.
• To represent the company in a professional and courteous manner.
• Any other task as required by the Technical Director.

Skills & Experience Required:

• Degree or equivalent certification in science related, medical, or engineering discipline.
• Substantial quality experience within the medical devices sectors ideally 5 or more years’ experience ie Manufacturing and/or Consultancy
• Experience in transition from EU Medical Directive EEC/93/42 to EU – MDR regulation
• Have the ability to assess all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly.
• Comprehensive understanding and Implementation of ISO 13485, ISO 14001, FDA 21 CFR Part 820, Canadian ISO 13485 into quality management systems from inception and to upgrade existing systems and knowledge of MDSAP.

• Experience with managing a team and have good interpersonal and communication skills
• Suitable general IT skills
• Internal Auditing experience (qualification necessary). Lead auditor certification.
• Experience in running supplier audits for medical devices.