Quality Systems Manager is urgently required for a permanent role in the Waterford area.
This position will be involved in the set up, maintain and improve the legal manufacturers QMS and to participate in the delivery of QMS changes for MDR implementation.
This position will perform activities required to maintain an agile, efficient quality system including developing & reporting relevant metrics to the global business unit leader for all applicable sites under the Legal manufacturer's responsibility as well as the generation and maintenance of relevant Quality Performance Metrics
- Setup, maintenance and continuous improvement of Quality Management System
- Responsible for updating the QMS for the legal manufacturer & business unit QMS to comply with existing & emerging quality regulations & standards
- Responsible for working with functions , outsourced processes & manufacturing to determine the legal manufacturer architecture , associated documentation and associated governance
- Lead the legal manufacturer audits with relevant authorities & internal compliance group
- MDR project activities as outlined by Manager
- Bachelor’s Degree in a quality, scientific or engineering discipline
- Minimum of 5 years related work experience in the Medical Device industry
- Thorough knowledge of Quality Systems, Quality Assurance, and regulatory requirements.
- Excellent report writing and documentation skills.
- Specific knowledge of legal manufacturer requirements as defined by EU legislation is necessary
- Broad regulatory and standards knowledge in the medical device sector
- Strong communication, collaboration, and decision making skills
- Ability to work effectively with minimal supervision.