Our client is seeking a skilled Software Quality/Validation Engineer to join it's team. This role offers the opportunity to join a global medical device organization.
Responsibilities
- The validation and operational management of computerized systems.
- The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
- Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
- Maintaining the quality and compliance status of associated Procedures, and work instructions.
- Presenting and communicating status, reporting metrics, identifying trends potential issues, and improvement initiatives, as applicable.
Qualifications and Experience
- Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
- 2-3 years of working knowledge of software validation in the medical devices industry.
- Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider the experience in pharmaceutical validations
Benefits
- Family health insurance,
- Excellent pension scheme
- Life assurance
- Career Development
- Fantastic new facility
- Growing business plus access to many more benefits.
For a confidential discussion and more information on the role, please contact Kevin Griffin.
kevin.griffin@collinsmcnicholas.ie
(021) 2427108
CMCNENG
Job Types: Full-time, Permanent
Pay: €50,000.00-€60,000.00 per year
Additional pay:
Benefits:
- Company events
- Company pension
- Employee assistance program
- On-site parking
- Sick pay
Schedule:
Work Location: In person
