Quality Engineer

Location:

Redmond, Washington

Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!

• Partnering with Operations and business functions to drive product and process quality performance.
• Addressing top quality concerns by collaborating with internal teams and suppliers.
• Owning and managing non-conformances (NC) and corrective action preventative action (CAPA) records in Trackwise, ensuring timely resolution.
• Supporting manufacturing-related complaint investigations and product field actions.
• Investigating and dispositioning non-conforming products within MRB, issuing NCs as needed.
• Communicating and collaborating with suppliers on non-conformances, escalating supplier corrective action requests (SCAR) when necessary.
• Overseeing supplier-initiated change requests (SICRs) and coordinating cross-functional assessments and approvals.
• Contributing to manufacturing transfers by executing quality activities for products transitioning between facilities.
• Driving supplier part certification initiatives and improving internal manufacturing processes for existing products.
• Assessing and qualifying internal and supplier-proposed change management activities, including conducting production part approval process (PPAP) for supplier changes.
• Leading or participating in the development, review, and enhancement of quality procedures.
• Supporting process and equipment validation/qualification and measurement systems analysis (MSA) for internal processes.
• Monitoring key performance indicators (KPIs), analyzing trends, and implementing improvements to ensure product quality.

• Bachelor’s degree in a Science, Technical, or related field required.
• Minimum of 2-4 years of experience in a quality assurance or engineering role, preferably in the medical device or regulated industry.
• Strong understanding of quality systems and regulatory standards such as ISO 13485, FDA QSR, or similar frameworks.
• Proven experience with quality management systems (e.g., Trackwise or equivalent electronic management tools).
• Proficiency in problem-solving methodologies (e.g., Root Cause Analysis, 8D, or DMAIC).

JBL is an Equal Opportunity Employer and E-Verify Company