Description:
We are working with a Global leader in the field of Medical Devices, Sterilisation, Cleaning & Infection Control. As part of our Client’s expansion, they are seeking a Quality Manager to join their site in Tullamore, Offaly on a full time permanent basis. Working alongside a seasoned Quality Director of Lab operations, you will carry out the following tasks:
Key Responsibilities
- Work in collaboration with the Lab Operations Management, Laboratory Tech Team, EO TechTeam and the Radiation TechTeam
- Ensure Quality System is in compliance with procedures, standards and applicable laws
- Ensure that Health and Safety Policies are correctly implemented and respected in Laboratories
- In collaboration with other departments, initiate, investigate, control and analyze non-conformance reports, complaints, supplier corrective action requests, deviations and OOS (Out of Specification) reports ensuring all relevant parties are informed and where appropriate, ensure appropriate corrective actions are implemented and effective.
- Facilitate Audits (Regulatory Inspections, Notified Body Assessments, Customer Audits, Supplier Audits) in collaboration with Operations Management. Ensure that the internal audit program is executed as per plan and perform audits as required.
- Manage changes to ISO 17025 accreditation scope, new or revised licenses.
- Manage change control in conjunction with lab operations. Ensure new equipment/instruments and quality related software are qualified and requalified either periodically or after modification prior to use.
- Manage and participate in local or global projects in collaboration with other departments and facilities.
- Monitor Laboratories performance through facilitation of quarterly facility management review.
- Facilitate Quality and GMP training of all laboratory personnel; develop, support and maintain the lab employee training program.
- Review technical documents including but not limited to equipment, methods, specifications, supplier technical agreements.
- Review Customer Quality Agreements.
- Provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend meetings with the Customers.