Overview
Quality Assurance Manager Jobs in Galway, County Galway, Ireland at Collins McNicholas Recruitment & HR Services Group
Title: Quality Assurance Manager
Company: Collins McNicholas Recruitment & HR Services Group
Location: Galway, County Galway, Ireland
Excellent opportunity for a QA Manager to join a Medical Device company in Galway. The QA Manager will be responsible for developing and managing the QMS for the company in Ireland and the ideal candidate will have strong systems experience in a med device manufacturing environment.
Overview of your responsibilities
- Act as QMS Management Representative.
- Maintain QMS compliance with ISO 13485, ISO 9001 & 21 CFR Part 820.
- Monitor QMS performance and drive continuous improvement.
- Promote regulatory and customer compliance across the business.
- Lead customer and certification body audits.
- Provide leadership on QA, compliance, quality systems & material disposition.
- Ensure compliant management reviews.
- Oversee QMS, product and manufacturing document control.
- Plan and conduct internal quality audits.
- Manage CAPA, customer complaints and feedback.
- Ensure effective and efficient Quality Control operations.
Knowledge, Skills and Experience Required for the Role:
- 5–10 years' QA/QC experience in medical device manufacturing or related industry.
- Strong leadership and people management skills.
- Knowledge of ISO 13485, FDA 21 CFR Part 820 and Medical Device Directives.
- Proficient in quality tools (FMEA, DOE, SPC & statistical analysis).
- Experience supporting product development, manufacturing & product release.
- Excellent technical writing and communication skills.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062
