Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Collection, Documentation, Manufacturing, Manufacturing Audit, Manufacturing Engineering, Manufacturing Systems, Medical Equipment, Process Failure Mode and Effects Analysis (PFMEA), Process Quality, Production Support, Quality Assurance, Quality Engineering, Validation Documentation, Validation Plan, Ventilator
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.
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Katalyst Healthcares & Life Sciences