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 discussionandmore information on the role,please contactKevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108
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