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Quality Assurance Engineer

  • Division: Engineering
  • Contact Email: kevin.griffin@collinsmcnicholas.ie
  • Job Ref: 24146

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