Company Information and Introduction:
Caragh Precision is a medical device manufacturing company and a leader in the manufacture of precision engineered products for the top global medical device companies. It has over 100 CNC Machining Centres and assists in all stages of the product lifecycle from concept realisation to manufacturing. Based in Parkmore Galway, it specialises in Cardiovascular, Structural Heart and Orthopaedics.
Key Responsibilities and Duties:
- Support the ongoing maintenance and continuous improvement of the QMS, ensuring compliance with ISO 13485, 21 CFR Part 820, and applicable medical device regulations.
- Assist in the preparation, coordination, and hosting of internal and external audits.
- Contribute to CAPA and non-conformance processes, including investigations related to customer complaints, audit findings, supplier issues, and internal quality events.
- Ensure all changes are appropriately evaluated through change control for impact on product quality, regulatory compliance, and business processes, and maintain accurate tracking through to closure.
- Perform and support incoming inspection and approval of raw materials.
- Generate, review, and maintain controlled documentation within the QMS.
- Develop, update, and improve procedures and process documentation as required.
- Provide quality guidance and feedback to cross-functional teams on a range of topics, including Change Control, CAPA, non-conformances, compliance with ISO 13485, 21 CFR Part 820 and customer requirements, documentation control, risk management, supplier quality management, and incoming inspection.
Key Skills and Competencies:
Minimum of 5 years’ experience in a regulated industry (preferably medical devices).- Third-level qualification in Science/Engineering or a related discipline, however a combination of experience and qualifications may be considered
- Strong analytical skills with demonstrated problem-solving and decision-making capabilities.
- High level of attention to detail and strong organisational skills.
- Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint, Teams).
- Excellent communication and interpersonal skills, with the ability to collaborate across functions and levels.
- Fluent in English (written and verbal).
- Strong team player with an innovative mindset and focus on continuous improvement.
