Process Validation Engineer/Manufacturing Engineer - Medical Device

Key Responsibilities

• Lead process qualification and validation activities to ensure manufacturing processes are robust and compliant
• Plan and execute IQ, OQ, PQ, and process validation activities
• Develop validation strategies, protocols, reports, and documentation (including URS)
• Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methods
• Perform test method validation and measurement system analysis (e.g., Gauge R&R)
• Provide Quality oversight for validation documentation and approvals
• Support deviation investigations, root cause analysis, and troubleshooting
• Collaborate with Manufacturing, Engineering, Supply Chain, and R&D teams to meet project timelines

Required Qualifications

• 5+ years of hands-on experience in process validation within regulated environments (GMP/ISO)
• 4+ years of experience in Quality, Supply Chain, or R&D within medical devices or similar industries
• Strong expertise in IQ/OQ/PQ, process verification, and validation documentation
• Experience with CNC machining processes and Coordinate Measuring Machines (CMM)
• Experience in risk management (FMEA)
• Strong communication, collaboration, and project management skills