Software Validation Engineer III / Quality Engineer III

About the role

The Software Validation Engineer III / Quality Engineer III will manage the Validation Master Plan for software, ensuring compliance with ISO 13485, QSR Part 820, and related regulations. This role supports plant validation activities, audits, and continuous improvement initiatives.

Key responsibilities

• Administer and maintain the Validation Master Plan for software validations and revalidations.
• Ensure compliance with ISO 13485, QSR Part 820, CFR Part 820, and GAMP 5 requirements.
• Maintain templates for protocol reports and perform annual reviews of the validation plan.
• Serve as SME for SAP and MES systems and support test script creation.
• Lead CAPA, NCMR, and complaint investigations related to software validation.
• Conduct internal and external audits, identify deficiencies, and drive corrective actions.
• Provide training on validation requirements and mentor less‑experienced engineers.

Required profile

• Demonstrated competence in software validation and quality engineering.
• Experience with regulated environments and standards such as ISO 13485, QSR Part 820, and GAMP 5.
• Ability to lead CAPA processes and support audit activities.

Required skills

• SAP
• MES