Excellent opportunity for a QA Supervisor to join an innovative Life Sciences company in the west of Ireland. As Quality Systems & Compliance Supervisor, you will report to the Site Quality Assurance Director and be responsible for ensuring the site's quality system complies with relevant standards, regulations, and policies.
Overview of your responsibilities (full job description available on request):
Develop and document a Quality System compliant with I.S. EN ISO 13485, EC Directive (93/42/EEC), and global and local quality policies.
Create procedures and plans to meet regulatory, business, and customer needs.
Ensure quality procedures are understood, implemented, maintained, and accessible to relevant staff.
Coordinate with Quality Assurance and regulatory bodies.
Conduct quality system audits with management as needed.
Ensure all products meet regulatory and customer standards.
Track and report Quality System performance through metrics for management reviews.
Monitor quality performance and advise management on critical issues.
Keep management informed of system failures and ensure corrective actions are taken.
Oversee and train quality personnel.
Knowledge, Skills and Experience Required for the Role:
Diploma or degree in Quality, Engineering, or Business-related disciplines.
Minimum of 6 years of relevant experience, with at least 2 years in a regulated manufacturing setting.
Experience in team management is highly advantageous.
Familiarity with ISO 13485 or ISO 9000 standards.
Strong communication and team-building abilities.
Energetic, enthusiastic, and quick to adapt to team environments.
Flexible and innovative approach to tasks.
Understanding of Medical Device Regulations.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062