Our client is seeking a skilled Quality Assurance Engineer to join their team. This role offers an exciting opportunity to contribute to a global medical device organization, ensuring the highest standards of quality and compliance in computerized systems.
Responsibilities:
- Develop and review validation documentation in line with regulatory requirements and internal quality policies.
- Conduct Software Compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet industry standards.
- Maintain and continuously improve the quality and compliance status of associated procedures and work instructions.
- Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives.
- Support audits and regulatory inspections by providing validation documentation and quality assurance insights.
Qualifications & Experience:
- A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
- 2-3 years of experience within the medical device industry.
- Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered.
Benefits:
- Family health insurance
- Excellent pension scheme
- Life assurance
- Career development opportunities
- State-of-the-art facility
- Growing business with access to additional benefits
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108