Quality Engineer

Position: Quality Engineer

Location: Tempe, AZ (On-site)

Duration: 12 months

Role Summary:

Quality Engineer responsible for ensuring quality and regulatory compliance in the development and manufacturing of Class III implantable cardiac and neuromodulation medical devices, with a focus on inspection optimization and microelectronics manufacturing.

Key Responsibilities:

• Lead inspection optimization projects (manual and automated inspections)
• Support process development, validation, and equipment qualification (IQ, OQPQ)
• Partner with process engineers on test method development and validation (Gage R&R, MSA)
• Maintain and apply quality standards for manufacturing operations

Required Qualifications:

• Bachelor’s degree with 4 years or Master’s degree with 2 years relevant experience
• 4 years in medical device manufacturing and process quality/engineering
• Experience in microelectronics, wafer fab, SMT, or chip & wire assembly
• Strong knowledge of ISO, FDA-GMP, and structured problem-solving (DMAIC, 8D)
• Proficiency in Microsoft Office tools