Our client is seeking a skilled Senior Software Quality 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, ensuring a strong understanding of the Quality Assurance role.
- Conduct Software Compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet industry standards and regulatory requirements, including familiarity with 21 CFR 820 and ISO 13485 regulations.
- Maintain and continuously improve the quality and compliance status of associated procedures and work instructions, ensuring high attention to detail and accuracy in all deliverables.
- Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives, demonstrating effective time management and organizational skills.
- Support audits and regulatory inspections by providing validation documentation and quality assurance insights, ensuring a smooth process during audits and inspections.
- Collaborate effectively with cross-functional teams, guiding them on validation tasks and ensuring alignment with best practices, while demonstrating strong interpersonal and conflict resolution skills.
- Handle software change management tasks, ensuring that changes comply with regulatory requirements and internal quality standards.
- Work as an individual contributor, without direct reports, yet maintaining strong teamwork skills and contributing to a positive, collaborative environment.
Qualifications & Experience:
- A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
- Hands-on experience with computer system validation deliverables.
- Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered.
- Knowledge of software change management and regulatory compliance standards.
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