NPI Quality Engineer - Medical Devices

Temporary full-time role based in Irvine, CA (onsite). Estimated duration: 7 months.

Pay

Hourly rate: $60.00 – $70.00.

Schedule

Monday – Friday, 8:00 AM – 5:00 PM.

Requirements

• Bachelor’s degree in Engineering, Physical Sciences, or Statistics
• Minimum 3 years of Quality Engineering or New Product Introduction (NPI) experience
• Experience collaborating with R&D, Advanced Operations, and Quality teams throughout the product lifecycle
• Strong knowledge of Process Risk Management (PFMEA), risk mitigation, and ISO 14971
• Experience developing inspection processes, inspection plans, and First Article Inspections (FAI)
• Experience supporting Design Transfer and cross-functional product launches
• Strong communication, problem-solving, and continuous-improvement skills

Preferred Qualifications

• Validation Quality Approver / Validation Representative experience
• PPAP and NPI Purchasing Controls experience
• Experience driving validation activities and process excellence

Responsibilities

• Support Quality Engineering activities for New Product Introduction (NPI) and product lifecycle projects
• Collaborate with R&D, Advanced Operations, and Quality teams to ensure successful product launches
• Lead Process Risk Management activities, including PFMEA, risk assessments, and mitigation plans
• Develop, implement, and improve inspection processes, inspection plans, and First Article Inspection (FAI) strategies
• Support validation activities, Design Transfer, and Process Transfer projects
• Manage PPAP and supplier quality activities for NPI
• Ensure compliance with ISO 14971 and applicable quality standards
• Drive continuous improvement initiatives to enhance quality, efficiency, and manufacturing processes