Quality Engineer - Medical Devices | CAPA & Supplier QA

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

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.