Design Quality Engineer III

Job Description This person develops, implements, and maintains quality engineering methodologies and systems that meet company, customer, and regulatory requirements, with a strong focus on patient safety and product quality. They serve as a quality representative supporting visibility, execution, and communication of quality initiatives across cross‑functional teams. Provides focused quality engineering support for product sustaining activities, including Design History File (DHF) remediation and design controls to ensure documentation is complete, consistent, and inspection‑ready. Supports DHF remediation through gap assessments, documentation creation and updates, risk management alignment, and end‑to‑end traceability between design inputs, outputs, verification, and validation. They also collaborate with R D, Manufacturing, Regulatory Affairs, and Document Control to drive remediation tasks to closure, maintain audit readiness, and ensure compliance within required quality systems. Applies systematic problem‑solving, sound judgment, and independent decision‑making under general direction to resolve complex quality and compliance issues while contributing to critical programs and projects. 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 HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• At least 3 years experience in the med device industry
• Functional understanding of design controls including experience developing, updating, and maintaining product Design History Files and Design Input / Output documentations (Product Specification, Component Specifications, and Prints)
• Functional understanding of risk controls including experience with updating and maintaining risk management documentation: DFMEA and Hazard Analysis