Job Description
Join a global medical device organization and work as a Computer Systems Validation Engineer. Key responsibilities include:
Validation and operational management of computerized systems
Creating and reviewing validation documentation in accordance with regulatory requirements and divisional policies
Conducting cybersecurity assessments such as 21 CFR Part 11 and Data Integrity, and maintaining quality and compliance status of associated Procedures and work instructions
Presenting and communicating status, reporting metrics, identifying trends and potential issues, and improvement initiatives
Key qualifications and experience:
Relevant third-level qualification, Engineering/Manufacturing/Science 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
Benefits include family health insurance, excellent pension scheme, life assurance, career development and access to many more benefits.