Job Description
The Principal Quality Engineer will lead risk management initiatives, ensuring compliance and driving strategic improvements for medical device safety and performance.
Key Responsibilities
• Serve as subject matter expert for ISO 14971 risk management processes.
• Lead development and maintenance of risk documentation and top-level risk files.
• Oversee corrective actions for field issues and ensure audit readiness.
• Guide team in sustaining activities and document control for long-term compliance.
• Mentor Sr. Quality Engineers and provide technical leadership on risk analysis methodologies.
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/.
Required Skills & Experience
• Bachelor’s degree in Engineering, Quality Management, or related field.
• 10-12+ years in regulated medical device environment.
• 5+ years in risk management and supervisory experience.
• Expertise in PFMEA, risk matrices, and safety risk analysis.
• Strong understanding of ISO 13485 and ISO 14971 standards.
• Experience working on integrated SW and HW devices - SAMD.
Nice to Have Skills & Experience
• ASQ certifications and QMS Lead Auditor certificate.
• Master’s degree preferred.
• Experience with large-scale enterprise systems and global compliance frameworks.
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.