This Irish owned manufacturer work with leaders in the Healthcare, Medical Devices, Automotive and Industrial industry sectors here in Ireland and abroad. They work with their customers to design, manufacture and assemble components that make their products successful in their chosen markets.
They are seeking a Quality Systems Technician to join their growing Quality team to focus on batch review, approval & release for medical products.
Duties and responsibilities of the Quality Systems Technician will include:
- Responsibility for final batch approval & release as per requirements of ISO13485: 2016. Complete batch review, maintain batch files and follow-up on GMP/GDP issues with relevant personnel as detected during batch review.
- Support the maintenance of the document control & calibration systems as per the requirements of the ISO13485: 2016 standard.
- Coordinate GMP/GDP training with all relevant personnel to ensure all customer & regulatory requirements are met.
- Maintain relevant quality system metrics for reporting at Management Review.
- Perform assigned internal audits as per the internal audit schedule. Track audits to successful completion, ensuring closure of all associated corrective & preventative actions.
- Support investigations associated with NCRs & CAPAs as an active member of the quality department.
You will have skills and experience in the following:
- BS or BEng in mechanical engineering, quality engineering, manufacturing engineering, or other technical discipline.
- 2+ years relevant industry experience.
- Strong written and verbal communications skills and interpersonal skills.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.