Software Quality Engineer

Our client is seeking a skilled 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

CMCNPRO1

Job Types: Full-time, Permanent

Pay: €50,000.00-€60,000.00 per year

Additional pay:

• Bonus pay

Benefits:

• Company events
• Employee assistance program
• Wellness program

Schedule:

• Monday to Friday

Work Location: In person