Quality Engineer

Job Description The Quality Engineer - Systems supports Quality R D activities for system and instrument product development by ensuring products are developed, tested, and transferred to manufacturing in compliance with

FDA QSR, ISO 9001, ISO

13485, IVDR, MDSAP, and other applicable regulations. This role serves as a Quality subject matter expert for design controls, risk management, verification and validation, and product lifecycle management, partnering closely with R D, program management, and cross‑functional teams to review and approve design documentation, maintain compliant Design History Files, and guide quality best practices across software, reagent, disposable, and full system development efforts. The position also supports post‑market activities, CAPA, audits, and inspections, identifies systemic process improvements, develops quality training, and helps ensure products remain safe, compliant, and state‑of‑the‑art throughout their lifecycle. 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 Bachelor's degree 5-10 years of experience in software engineering, quality engineering, or instrumentation Experience supporting software and/or instrument design in new product development Strong knowledge of quality and regulatory standards (ISO 9001 required; ISO 13485 and IVDR preferred) Ability to serve as the quality voice on cross‑functional microbiology projects (software, instruments, reagents) Experience ensuring regulatory and quality compliance throughout development and testing