Quality Assurance Manager

I am looking for a Quality Assurance Manager to join a medical equipment manufacturing company based near Bristol - The ideal candidate will have either IVD or medical device industry experience and a solid understanding of the operation and maintenance of a ISO13485 structured quality management system.

The Position:

To act as a conduit for the effective operation of the QMS. To provide a professional quality assurance support role for the internal organisation, supplier quality interfaces and customer quality interfaces as required. A Quality professional with a sound practical background in the application of ISO13485 quality principles within the IVD or Medical Devices Industry.

The successful applicant will be able to demonstrate the ability to support the implementation and maintenance of an integrated QMS that meets the requirements of ISO13485 / 21 CFR Part 820 compliance, other regulations, and effective business processes. A self-motivated individual is required as this role will involve working with and across all internal departments. The role may also require communication with suppliers and customers.

The ideal applicant will have experience with software validation, either as a stand-alone medical device or incorporated within a medical device.

Responsibilities:

• Advise and support organizational leaders in furthering the company’s goals.

• Prioritize, assign, and monitor the workload of QA team members.

• Lead and support the implementation of QMS processes

• Act as a system administrator for the eQMS system (QT9)

• Train employees companywide in QMS procedures owned by QA, as required

• Audit processes and QMS procedures for compliance and effectiveness

• Support and advise operational staff in the execution of the QMS processes

• Monitor key performance indicators

• Support the on-going development of the Quality Management System and the application of other relevant regulatory requirements

• Provide backup QA team resource for the day-to-day administrative requirements of the quality management system.

• Identify quality improvements and implement efficiencies.

Education, Experience and Demonstrated Skills:

• BSc in a relevant Scientific discipline, or equivalent experience

• Recognised qualification from a relevant quality institute

• A minimum of 5 years hands-on supporting the development, operation and maintenance of a ISO13485 structured quality management system

• A minimum of 2 years’ hands-on experience in the IVD or medical device industry

• Skilled in collaboration and working in cross-functional groups to achieve positive outcomes

• Experience in process-based auditing

• Strong understanding of ISO13485

• Strong understanding of 21 CFR Part 820

• Basic understanding of IVD Directive (98/79/EC)

• Basic understanding of ISO14971

• Ability to write controlled documents like SOPs

• Ability to train others

• An understanding of the role of quality in a business context

• Strong verbal & written communication

• Ability to operate electronic QMS systems (including document control)

• Working to deadlines

• Attention to detail

• Ability to formulate and ask open-ended questions

• Competent in word processing, spread sheets, databases

For interested applicants, please submit resumes to