Non-Product Software Validation Engineer

About the role

As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non‑product software and computerized systems used in a regulated medical‑device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers and project teams to ensure systems are fit for intended use, compliant, inspection‑ready and maintained in a validated state.

Key responsibilities

• Provide quality oversight across the full computerized system lifecycle, including classification, validation planning, risk assessment, test strategy, release and change control.
• Develop, implement and maintain validation deliverables, procedures and guidance for CSV and Computer Software Assurance.
• Advise Agile, DevOps, cloud and SaaS projects on compliant lifecycle controls and objective evidence.
• Lead cross‑functional resolution of complex quality and compliance issues and drive improvements in validation efficiency and inspection readiness.

Required profile

• Bachelor’s or master’s degree in engineering, computer science, life sciences or related field, or equivalent experience.
• At least 8 years of experience in computerized systems, software quality or validation within highly regulated life‑science industries.
• Hands‑on experience authoring and approving CSV/CSA deliverables for complex systems.
• Strong knowledge of risk‑based validation, data integrity, electronic records and signatures, and change control.

Required skills

• Agile and DevOps methodologies.
• Cloud and SaaS platforms.
• Enterprise Resource Planning (ERP) and Quality Management System (QMS) tools.
• Manufacturing analytics environments.