Supplier Quality Engineer

Katalyst HealthCares and Life Sciences

$80K — $110K *
US-AnywhereRemote in Bothell, WA
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 6+ years of experience in Manufacturing Quality, Supplier Quality, Process Quality, or Validation
  • Proven track record with CAPA and audit support
  • Familiarity with validation protocols and quality systems
  • Ability to thrive in regulated manufacturing environments
  • Experience in Medical Device manufacturing
  • Hands-on experience with production transfers and supplier quality activities
  • Knowledge of respiratory or sleep therapy products

Responsibilities

  • Support manufacturing quality systems and daily quality assurance activities
  • Assist in validation protocol execution and production builds
  • Update PFMEA and monitor inspection activities
  • Aid in CAPA and quality notification tracking
  • Collaborate with supplier quality and manufacturing engineering teams during transitions
  • Perform data collection, analysis, and documentation for quality activities
  • Participate in compliance audits and continuous improvement initiatives
  • Support production line and design transfer activities

Benefits

  • Opportunity to work on cutting-edge medical devices
  • Collaborative and regulated work environment
  • Involvement in continuous improvement initiatives
  • Professional growth and development opportunities
  • Exposure to a wide range of quality assurance activities
Full Job Description
Summary :
Support manufacturing quality, validation, supplier quality, and production transfer activities during execution of the Philips manufacturing transfer program.
Roles & Responsibilities :
  • Support manufacturing quality systems and day-to-day quality assurance activities.
  • ssist in execution of validation protocols, production builds, and process verification activities.
  • Support PFMEA updates, process monitoring, inspection activities, and quality documentation.
  • ssist 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.
  • bility 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.

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