Quality Assurance Supervisor

Are you looking for the next step in your career? If so, this role is for you. We are delighted to be working with a leading medical device client on a permanent Quality Systems Supervisor position: As Quality Systems & Compliance Supervisor, you will be reporting to the Site Quality Assurance Director with responsibility for maintaining the site quality system in compliance with all applicable quality system standards and regulations. Major Responsibilities

1. Documenting and establishing a Quality System which assures compliance with the requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), and Corporate and International Quality Policies and Procedures.
2. Establishment of procedures and plans that define those elements necessary to meet regulatory, business, and customer requirements.
3. Ensure that quality procedures and instructions are understood, implemented, maintained, and accessible to the appropriate personnel.
4. Liaison with wider Quality Assurance and regulatory authorities bodies.
5. Auditing the quality system with other management personnel, when required.
6. Ensure all manufactured products meet the requirements of regulatory authorities, end users, and company.
7. Responsibility for measuring performance of the Quality System and providing metrics for management review meetings, monthly reports, etc., and at other frequencies as defined in relevant quality system procedures.
8. Monitoring quality performance and advising management personnel on major quality issues.
9. Ensure management are kept informed of all system failures on a regular basis to ensure corrective or preventive action is undertaken where required.
10. Supervision and training of relevant quality personnel.
11. Disposition of product non-conformances.
12. Review and approval of change control/validation packages.
13. Coordination of product actions (recall, withdrawal, or stock recovery) from the marketplace, where required.

1. The position has responsibility for managing several direct reports in the Quality Department.
2. The position has responsibility for deputizing for the Site Quality Assurance Director when required.

1. Frequent contacts with company personnel at many levels, Division, Affiliate, and other plants.
2. Close contact with plant personnel at all levels.

1. Diploma/Degree in a Quality Related, Engineering, or Business-related discipline.
2. A minimum of 6 years relevant work experience at least 2 of which in a regulated manufacturing environment.
3. Previous experience in Team Management a distinct advantage.
4. Additional training or experience in quality systems standards ISO 13485, or ISO 9000.
5. Excellent communication skills.
6. Strong Team building skills.
7. Enthusiastic and energetic with the ability to integrate quickly into a team environment.
8. Demonstrated flexible and innovative approach to work.
9. Knowledge of Medical Device Regulations.