Supplier Quality Engineer

Roles & Responsibilities

• Support manufacturing quality systems and day-to-day quality assurance activities.
• Aid in the execution of validation protocols, production builds, and process verification activities.
• Support PFMEA updates, process monitoring, inspection activities, and quality documentation.
• Aid 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 preferred.
• Experience supporting production transfers, validation execution, or supplier quality activities.
• Respiratory, ventilator, CPAP, or sleep therapy product experience is a plus.