Senior Supplier Quality Engineer: Manufacturing & Validation

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

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.