Quality Engineer II

What you'll do

• Develop, modify, and maintain quality standards and protocols for processing materials into finished products.
• Ensure internal quality processes and systems comply with all governing regulatory standards.
• Design and implement methods for inspecting, testing, and evaluating the precision of products and production equipment.
• Perform statistical analysis to assess costs and determine responsibility for products that fail to meet specifications.
• Support manufacturing development through process validation, including equipment development, IQ, and test method validation.
• Conduct risk assessments using tools like process FMEA to ensure documentation meets all requirements.
• Lead investigations into non-conforming products or processes by coordinating cross-functional teams.
• Manage change control procedures and collaborate with owners on implementation strategies and documentation.

What we're looking for

• Candidates must have a Baccalaureate degree in Engineering, Science, or a technical field with at least 2 years of relevant experience.
• Candidates may hold a Master's degree in Engineering, Science, or a technical field with no minimum years of experience required.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Candidates must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly is preferred.
• A solid background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation is preferred.
• Six Sigma or Lean Sigma belt certification is preferred.
• Experience supporting internal or external audits including FDA, MDSAP, and/or TUV is preferred.