Supplier Quality Technician

Katalyst CRO; New Kensington (Westmoreland County); On-site; USD 60,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Quality Assurance professional to support manufacturing quality, validation, supplier quality, and production transfer activities during the Philips manufacturing transfer program.

This role involves day-to-day quality assurance, execution of validation protocols, CAPA, audits, and documentation, with collaboration across manufacturing and supplier teams in a regulated environment. Experience in medical device manufacturing and transfer projects is preferred.

Qualifications

• 2+ 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.

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 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

Manufacturing Quality

Supplier Quality

Process Quality

Validation

Job description

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

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

Requirements

• 2+ 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.

Preferred Experience

• Medical Device manufacturing environment.
• Experience supporting production transfers, validation execution, or supplier quality activities.
• Respiratory, ventilator, CPAP, or sleep therapy product experience.