Senior Quality Engineer

Senior Quality Engineer

Citizenship Requirement:
U.S. Citizen, Green Card holder, or TN Visa only. (No OPT or other visa types considered.)

Location: Tempe, AZ (100% On-Site)
Employment Type: Contract
Duration: 12+ Months
Company: Confidential

Position Overview

The Senior Quality Engineer is responsible for ensuring quality and regulatory compliance throughout process development and manufacturing of Class III implantable medical devices, including cardiac and neuromodulation products. The initial focus of this role will be on Inspection Optimization initiatives, with additional responsibilities supporting quality activities within microelectronics manufacturing operations, including IC and wafer assembly.

Key Responsibilities

• Lead and manage Inspection Optimization projects across multiple microelectronics assembly processes, including manual, semi-automated, and automated inspection systems.
• Serve as the Quality representative supporting process development, validation, and continuous improvement initiatives within manufacturing operations.
• Support equipment development and qualification activities, including IQ, process characterization, and OQPQ, ensuring compliance with regulatory and internal quality standards.
• Partner with Process Engineers to develop, execute, and validate test methods, including both attribute and variable Test Method Validations (TMV), Gage R&R, and MSAs.
• Develop, maintain, and apply quality standards, procedures, and protocols for processing materials into in-process and finished medical device products.
• Ensure compliance with applicable FDA, ISO, and GMP regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering with 4+ years of relevant experience

OR Master's degree in Engineering with 2+ years of relevant experience

• Minimum 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience
• Strong experience in equipment development, IQ, process characterization, OQPQ, and test method development and validation
• Hands-on experience with electronics manufacturing, including wafer fabrication and microelectronics assembly (SMT and/or chip & wire)
• Strong knowledge of regulatory standards (FDA GMP, ISO, etc.)
• Proficiency in structured problem-solving methodologies (DMAIC, 8D, Ishikawa, etc.)
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Teams)

Preferred Qualifications

• DRM or DFSS certification
• Experience supporting internal and external audits (FDA, MDSAP, TÜV)
• Six Sigma or Lean Six Sigma certification
• Strong background in statistical analysis and DOE
• In-depth understanding of medical device manufacturing processes and products

Job Type: Contract

Pay: $ $40.00 per hour

Work Location: In person