Senior Quality Engineer

Job Description Insight Global is looking for a Senior Quality Engineer to support a new product development project. This role is responsible for managing risk management documentation across the product lifecycle, including maintaining risk files for marketed products, supporting the development of new product risk documentation, and improving overall risk management systems. The position ensures compliance with ISO 14971 and regulatory requirements by reviewing submissions, responding to regulatory inquiries, and staying current on evolving standards. It also supports audits, monitors risk metrics, and escalates changes in product risk profiles as needed. The role partners cross-functionally with teams such as Medical Safety, Manufacturing, and Post-Market Surveillance to ensure alignment, while providing regular reporting, facilitating meetings, and driving continuous process improvements. 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

• 4-5+ years of experience in quality engineering
• Medical device (or highly regulated industry) experience
• Risk Management experience (ideally 2+ years)

ISO 14971

knowledge

• Quality Systems experience (QMS, CAPA, GDP, change control)
• FDA / regulatory exposure
• Strong documentation & risk file management experience
• Complaint handling / post-market surveillance
• Health Hazard Evaluation experience
• Regulatory submissions or responses to agencies
• Cross-functional collaboration (Medical Safety, NPD, Manufacturing, etc.)
• Audit/inspection support experience
• Project management or process improvement background