Quality Assurance Engineer

2 weeks ago

Kilkenny, Kilkenny, Ireland Collins McNicholas Recruitment Full time
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:

1. Develop and review validation documentation in line with regulatory requirements and internal quality policies.
2. Conduct Software Compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet industry standards.
3. Maintain and continuously improve the quality and compliance status of associated procedures and work instructions.
4. Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives.
5. Support audits and regulatory inspections by providing validation documentation and quality assurance insights.

Qualifications & Experience:

1. A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
2. 2-3 years of experience within the medical device industry.
3. Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered.

Benefits:

1. Family health insurance
2. Excellent pension scheme
3. Life assurance
4. Career development opportunities
5. State-of-the-art facility
6. 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

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