We are in search of a Quality Technician to join a Medical Devices company in Sligo. The Quality Technician will report to the QA Manager and support the Quality Engineering team in regards to batch record reviews, managing the QMS and supporting on customer and regulatory audits. The ideal candidate will have 2 years medical devices experience.
Overview of your responsibilities:
- Issue and release manufacturing batch records
- Support change controls and QMS improvement
- Work with Quality/clients on compliant product specs
- Assist with non-conformances, complaints, and CAPAs
- Conduct internal audits and maintain documentation
- Support NPI and audit preparation
- Generate quality metrics and liaise with suppliers/clients
- Archive and manage quality records
Knowledge, skills and experience required for the role:
- 2+ years medical device assembly experience
- Strong computer skills
- Knowledge of ISO 13485 and FDA 21 CFR 820
- Internal audit experience (preferred)
- Independent decision-maker; able to multitask and prioritise
- Strong interpersonal and organisational skills
- Excellent attention to detail
- Clear written and verbal communication with teams, suppliers, and customers
- Self-motivated, flexible, and eager to learn
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
