-
Job Description
Skilled Computer Systems Validation Engineer sought for global medical device organization. Summary: Experienced professional required for software change management and cybersecurity assessments.
The ideal candidate will be responsible for the validation and operational management of computerized systems, creating and reviewing validation documentation in accordance with regulatory requirements and divisional policies. Key responsibilities include:
- 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 and potential issues, and improvement initiatives
Requirements and qualifications:
- Rlevant third-level qualification in Engineering, Manufacturing, or Science
- 2-3 years of working knowledge of software validation in the medical devices industry
- Experience working in a 21CFR820 and/or ISO13485-regulated industry
Benefits:
- Family health insurance
- Excellent pension scheme
- Life assurance
- Career development opportunities
Benefits continue to grow with the company, offering a fantastic new facility and access to many more benefits.