Job Description
The Quality Engineer is responsible for ensuring that all products, processes, and systems comply with applicable global regulatory requirements and internal quality standards. This role supports manufacturing operations, leads quality investigations, drives continuous improvement, and serves as a subject matter expert in quality systems, validation, and risk management.
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
· A minimum of four (4) years of relevant professional work experience in the Medical Devices industry.
· Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR).
· Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
· Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
· Experience with CAPAs non-conformances, audits, and process validation.
· Strong trending and data analysis skills.
· Troubleshooting expertise.
· Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.
· Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.
Nice to Have Skills & Experience
Industrial Engineering Background
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.