Supplier Quality Engineer

Katalyst CRO; Bothell (WA); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Quality professional in Washington state to support quality systems, validation, and supplier quality during complex product transfers. You will work in a regulated medical device environment, contributing to CAPA tracking, audits, and continuous improvement initiatives.

Ideal candidates bring 6+ years in manufacturing quality, experience with validation, PFMEA, and documentation, and a background in respiratory or related medical devices.

Qualifications

• 6+ years of experience in Manufacturing Quality, Supplier Quality, Process Quality, or Validation.
• Experience supporting CAPA, Client, audits, and process quality activities.
• Familiarity with validation activities, documentation, inspection, and quality systems.
• Ability to work in manufacturing and regulated environments.
• Medical Device manufacturing environment.
• Experience supporting production transfers, validation execution, or supplier quality activities.
• Respiratory, ventilator, CPAP, or sleep therapy product experience.

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

Data analysis

Job description

Summary

Support manufacturing quality, validation, supplier quality, and production transfer activities during execution of the Philips manufacturing transfer program.

• 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.

Roles & 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.

Education & Experience

• 6+ years of experience in Manufacturing Quality, Supplier Quality, Process Quality, or Validation.
• Experience supporting CAPA, Client, audits, and process quality activities.
• Familiarity with validation activities, documentation, inspection, and quality systems.
• Ability to work in manufacturing and regulated environments.
• Medical Device manufacturing environment.
• Experience supporting production transfers, validation execution, or supplier quality activities.
• Respiratory, ventilator, CPAP, or sleep therapy product experience.