Quality Manager- Medical Devices
The Quality Manager will provide leadership and maintain the Quality System to a world class standard. The successful candidate will be responsible for the management, direction, and coordination of all quality and regulatory activities for the site.
This permanent position will report to the Plant Manager.
Quality Manager Responsibilities:
- Ensure department KPI’s and objectives are met – safety, quality, complaint analysis, product conformances.
- Ensure achievement of recognised quality standards (ISO13485 & 22416) and legal compliance.
- Site lead for Notified Body and customer audits.
- Approval of Technical Transfers and Quality Agreements.
- Audit contractors and suppliers etc. to ensure they comply with site standards.
- Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance by developing key supplier partnerships
- Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence.
- Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards.
- Any other duty assigned within the skill of the employee.
Quality Manager requirements:-
- Requires a Bachelor’s degree in Quality / Science / Engineering or other Technical field
- 10 years of manufacturing experience working in a quality assurance role in a regulated environment.
- 5-7 years, people management experience.
- Must have an understanding of common problem-solving tools such as statistical analysis, DOE, Pareto charts and histograms.
- Experience in Lean Six Sigma with certification required.
- Audit experience.
For a confidential discussion and more information on the role, please contact Tina Egan.