Supplier Quality Engineer​/Quality Enginere

Job Description

Our client is seeking an experienced Supplier Quality Engineer (SQE) / Quality Engineer (QE) to support critical validation initiatives for two of their large programs.

The ideal candidate brings strong quality and validation experience and is comfortable working cross-functionally with engineering and validation teams in a regulated environment.

• Partner with the Validation Engineering team to support and execute overall validation strategy for said project.
• Review and provide quality oversight of development lifecycle and validation documentation, including but not limited to:
  • User Requirements Specifications (URS)
  • Functional Requirements Specifications (FRS)
  • Design Validation documentation
  • Failure Modes and Effects Analysis (FMEA)
  • Traceability Matrix
  • Development Reports / Characterization Reports
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Reports
• Ensure documentation complies with quality system and regulatory expectations
• Support and participate in the change control process in the SQE/QE capacity
• Collaborate with cross-functional stakeholders to identify quality risks and ensure timely resolution
• Provide clear, concise feedback and guidance to project teams to maintain validation and quality standards

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to  To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

• Minimum of 4 years of experience working in Quality Engineering or Supplier Quality roles
• Prior experience supporting validation activities or similar regulated quality areas
• Strong understanding of validation principles and development lifecycle documentation
• Experience working in a regulated manufacturing, engineering, or medical device environment preferred
• Strong attention to detail and ability to work independently while managing multiple priorities
• Bachelor's Degree