Senior Quality Engineer (Risk Management)

Seeking experienced Sr. Quality Engineers to join the Risk Management team for a leading medical device organization. These roles will focus on risk analysis, document maintenance, and supporting design changes and sustaining activities.
Key Responsibilities
• Own and maintain risk documentation (PFMEAs, risk files) across multiple product lines.
• Perform risk analysis including FMEA, risk management matrices, and safety risk assessments.
• Support sustaining engineering activities, including design changes and corrective actions for field issues.
• Ensure compliance with ISO 13485 and ISO 14971 standards.
• Collaborate cross-functionally to articulate risk management strategies during audits.
• Assist in remediation and updates of high-volume risk files (top-level: ~30; low-level: hundreds).

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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• Bachelor’s degree in Engineering, Quality Management, or related field.
• 6-8+ years in regulated medical device or pharmaceutical environment.
• 4-5+ years in risk management within medical devices (preferably patient monitoring systems).
• Strong experience with PFMEA ownership and updates.
• Familiarity with adverse event reporting and safety risk analysis.
• Experience working on integrated SW and HW devices - SAMD.

• ASQ certifications (CSQE, CQE, SSBB, SQE).
• QMS Lead Auditor certification.
• Master’s degree in Engineering or Quality Management.
• Experience in enterprise-level organizations (Abbott, ThermoFisher, etc.).

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.