Supplier Quality Engineer — Manufacturing Transfer & Validation

Katalyst CRO; Bothell (WA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Bothell, WA seeks an experienced Manufacturing Quality professional to support quality systems, validation, supplier quality, and production transfer activities during a regulated manufacturing transfer program.

The role emphasizes CAPA, audits, process verification, data collection and documentation, with collaboration across manufacturing, quality, and supplier teams to ensure compliant delivery of medical device products.

Qualifications

• 6+ years in manufacturing quality or validation roles in medical devices.
• Experience with CAPA, audits, and quality documentation.
• Familiarity with validation activities, inspection, and quality systems.
• Ability to work in regulated manufacturing environments.

Responsibilities

• Support manufacturing quality systems and day-to-day quality assurance activities.
• Assist in execution of validation protocols, production builds, and process verification activities.
• Support PFMEA updates, process monitoring, inspection activities, and quality documentation.
• Assist with CAPA, Client, Quality Notifications, and corrective action tracking.
• Support supplier quality and manufacturing engineering teams during transfer and sustaining activities.
• Perform data collection, analysis, reporting, and documentation required for validation and quality activities.
• Participate in manufacturing audits, compliance activities, and continuous improvement initiatives.
• Support production line transfer and design transfer execution activities.

Skills

Quality systems

CAPA management

Audits

Validation

Process quality

Data analysis

Job description

Katalyst CRO in Bothell, WA seeks an experienced Manufacturing Quality professional to support quality systems, validation, supplier quality, and production transfer activities during a regulated manufacturing transfer program.

The role emphasizes CAPA, audits, process verification, data collection and documentation, with collaboration across manufacturing, quality, and supplier teams to ensure compliant delivery of medical device products.