Description
My client, a global leader in the Medical Device industry, is currently recruiting for the role of Quality Manager to be based in Cork. The successful candidate will be responsible for the provision of strong technical and project leadership for the Quality department. This role includes the management and development of the Quality Assurance Departments which includes Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling and Laboratory Services to ensure that products manufactured and established systems comply with GMP, ISO and applicable regulatory and company requirements.Responsibilities:
- Perform the duties as Facility Management Representative in accordance with FDA and ISO requirements to ensure overall Quality System is implemented and effective
- Ensure that processes needed for the quality system are established, implemented and maintained. Maintain the facility compliance to FDA QSRs, ISO 13485, applicable MDD and Canadian requirements together with other applicable International Standards and regulatory requirements
- Report to management on the performance of the quality system and any need for Improvement.
- Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization. Promote process improvements through the use of recognised quality tools, internal audit program, appropriate CAPA systems and feedback systems (complaints etc.)
- Implement systems and controls to Prevent Product Recalls and manage post market surveillance actions in accordance with regulations and corporate requirements. Maintain responsibility for the systems that control/ensure the sterility of product and the release of product to the marketplace.
- Responsible for registration of products in all identified marketplaces to support start build plan requirements and for maintaining registrations current.
- Maintain a change control system with appropriate controls which comply with applicable regulations.
- Manage and maintain a suitably resourced Quality Dept. with appropriately qualified personnel to support facility needs and comply with international regulations. Manage personnel over various shifts.
- Actively participate in and contribute to Site Leadership meetings.
Candidates should have:
- Bachelor Degree in Engineering or relevant Science discipline
- Minimum 5 - 10 years' experience in a Medical Device or related field having comparable technology and regulatory requirements. Five years people management experience.
- Knowledge of appropriate Regulations and Standards.
If you are interested in applying for this role please apply directly to this advert or contact Derek Sheridan on for further detail. Sthree UK is acting as an Employment Agency in relation to this vacancy.