Insight Global is looking for a Medical Device Quality Engineer in St. Petersburg, FL. This person will be responsible for managing production controls in adherence to ISO 13485 and FDA QSR. Other responsibilities include, understanding of manufacturing process validation activities, participate in design reviews, FMEAs, and risk assessments. This person should also have a background in continuous improvement practices and define more efficient assembly processes.
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 Engineering (Mechanical, Biomedical, or Industrial)
- 3+ Years Quality Engineering in Medical Device Industry specifically with ISO 13485 standards.
- 5+ years experience in NPI (New Product Introduction) and process validation, and able to navigate complex regulatory environments effectively.
- Design Control exposure is a plus.
- Certifications such as CQE or Six Sigma Belt/Black Belt preferred
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.