Job Description
Insight Global is seeking a Quality Engineer to support a leading medical device manufacturer’s Cardiology division, focused on identifying actionable root causes and implementing effective solutions for high‑visibility issues impacting Active Implantable and Accessories product performance. This role is ideal for a technically curious engineer looking to build leadership, complex problem‑solving, and project management experience while leading cross‑functional investigations into design‑related product performance issues, including NCEPs, CAPAs, and potential field actions. The Quality Engineer will collaborate closely with Research & Development, Regulatory, Manufacturing, Medical Safety, Marketing, Post‑Market, and other Quality teams, leveraging structured problem‑solving methodologies to drive compliant, well‑documented outcomes, support risk management, new product development, and sustainment activities, and uphold the highest standards of patient safety and product quality.
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 (ideally systems or electrical engineering)
- 4+ years of experience as an engineer
○ Background as Systems Engineer or Electrical Engineer helpful
- Experience with CAPAs, field action decision making and other investigation processes
- Medical Device industry experience
Nice to Have Skills & Experience
- Experience with Active Implantable medical technologies
- Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)
- Strong ability to successfully multi-task and demonstrate adaptability
- Project management experience (direct or cross-functional teams)
- Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
- Ability to collaborate and influence across multiple, cross-functional teams
Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
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.