Supplier Quality Engineer

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)
• Failure Modes and Effects Analysis (FMEA)
• Traceability Matrix Development Reports / Characterization Reports
• 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.

• 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.