Senior Quality Engineer, Validation

About the role

The Senior Quality Engineer, Validation provides cross‑functional support for verification and validation (V&V) activities across medical device processes, materials, equipment and methods. The role is results‑oriented and suited for candidates with advanced expertise in quality assurance and V&V.

Key responsibilities

• Provide hands‑on engineering assistance for V&V requirements, including project management, process design, and document generation (IQ, OQ, PQ, SOPs, WIs, ETSs).
• Develop and execute inspection and test methods for feasibility and qualification projects.
• Lead validation of corporate software packages ensuring regulatory compliance.
• Apply statistical techniques and risk‑based approaches (pFMEA, FMEA, GEPs) to design and execute V&V activities.
• Prepare and maintain V&V documentation, audit programs, and validation project dashboards.
• Identify, analyze, and correct manufacturing deviations related to V&V, supporting cross‑functional teams.
• Communicate quality and compliance concerns early in the V&V development phase and inform Regulatory Affairs of relevant projects.
• Oversee corrective and preventive actions arising from non‑conformances, recalls, or field issues.

Required profile

• Senior‑level experience in quality assurance and validation/verification for medical devices.
• Strong knowledge of industry regulations and corporate quality systems.
• Results‑oriented with the ability to lead and collaborate across functions.
• Excellent documentation and analytical skills.

Required skills

• Statistical analysis techniques
• pFMEA and FMEA
• Good Engineering Practices (GEPs)
• IQ, OQ, PQ documentation
• SOPs, Work Instructions (WIs), Equipment Transfer Specifications (ETSs)
• Process design and validation of software packages