Software Validation Engineer

Description:

Our client is seeking a highly skilled Software Quality/Validation Engineer with a strong background in the Med-device industry. As part of the team, you will play a crucial role in ensuring the quality and compliance of their software products.

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