Sr Quality Engineer

Job Description Insight Global is seeking an experienced, highly skilled Sr Quality Engineer to support an established medical supply client out of Redmond, OR.

Key Responsibilities:

Develop and implement procedures for QMS, process control, validation, improvement, testing, and inspection. Partner with suppliers to resolve quality issues, ensuring corrective actions (CAPA, SCAR) are implemented. Provide Quality expertise in Product Development, Design Control, Risk Management, Validation, and QMS processes. Build and maintain Device Master Records (DMRs) in compliance with regulations. Collaborate with Regulatory Groups and internal departments to support 510K submissions and related documentation. Ensure compliance with domestic and international regulations. Perform quality reviews of design documentation, validation documentation, and company quality records. Lead investigations of product/process non-conformances and out-of-specification results. Develop and implement effective corrective and preventive actions. Train and mentor team members and employees on quality 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 HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Bachelor's degree in engineering 5+ years of experience within Quality in a manufacturing setting Familiar with

ISO/FDA/CFR 820

regulations Industry preference: Pharmaceutical, medical device, aerospace

Skills:

Adaptive, cross-functionally collaborative, strong project management skills Experience with validation, software/process/equipment Quality management system (QMS) experience, preferably ETQ Reliance Experience with training program administration