Senior Quality Assurance Engineer

Insight Global is seeking an experienced Senior Quality Engineer to support an established medical supply client in Redmond, OR. This individual will be responsible for developing and improving Quality Management System (QMS) processes, validation procedures, testing, inspection programs, and overall quality initiatives. They will partner with suppliers to resolve quality issues, lead corrective and preventive action activities, and provide expertise across product development, design control, risk management, and validation efforts. The role will also support regulatory compliance through maintaining Device Master Records (DMRs), assisting with 510(k) submissions, reviewing quality and validation documentation, investigating non-conformances, and ensuring adherence to domestic and international regulations. Additionally, this person will help train and mentor team members on quality standards, processes, and best practices.

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 View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:


Required Skills & Experience

Bachelor's degree in engineering, bioscience + biomechanical, electrical engineering
5+ years of experience within Quality in a manufacturing setting (preferred)
Familiar with ISO 13485/FDA/CFR 820 regulations
Experience with Erp systems (SAP, EPQ)
Skills: Adaptive, cross-functionally collaborative, strong project management skills


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.