Quality Engineer

JBL Resources; Redmond (WA); On-site; USD 70,000 - 100,000; Full time

Job summary

JBL Resources in Redmond, WA seeks a Quality Engineer to ensure product and process quality across operations. You will own CAPA, track non-conformances, and work with suppliers to resolve issues while supporting PPAP and change controls.

The role requires a science/engineering degree, 2–4 years in QA/engineering in regulated settings, and strong knowledge of ISO 13485/FDA QSR. Join a team focused on delivering high-quality medical devices.

Qualifications

• Bachelor's degree in a Science, Technical, or related field.
• 2-4 years of experience in a quality assurance or engineering role, preferably in 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).
• Proficiency in problem-solving methodologies (8D, DMAIC, Root Cause Analysis).

Responsibilities

• Partner with Operations and business functions to drive product and process quality performance.
• Address top quality concerns by collaborating with internal teams and suppliers.
• Own and manage non-conformances (NC) and CAPA records in Trackwise; ensure timely resolution.
• Support manufacturing-related complaint investigations and product field actions.
• Investigate and disposition non-conforming products within MRB; issue NCs as needed.
• Communicate and collaborate with suppliers on non-conformances; escalate SCAR when necessary.
• Oversee SICRs and coordinate cross-functional assessments and approvals.
• Contribute to manufacturing transfers by executing quality activities for products transitioning between facilities.
• Drive supplier part certification initiatives and improve internal manufacturing processes for existing products.
• Assess and qualify internal and supplier-proposed change management activities, including PPAP for supplier changes.
• Lead or participate in developing, reviewing, and updating quality procedures.
• Support process and equipment validation/qualification and MSA for internal processes.
• Monitor KPIs, analyze trends, and implement quality improvements.

Skills

Root Cause Analysis

DMAIC

8D

Education

Bachelor's degree in Science/Engineering/Technical field

Tools

Trackwise

Job description

Quality Engineer

Location: Redmond, Washington

About Our Client

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!

Key Responsibilities

• 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.

Qualifications

• 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