Job Opportunity
The role entails serving as the primary contact for quality assurance, assessing and ensuring that manufacturing contractors' processes and systems meet all quality control standards.
Key Responsibilities:
* Contract Manufacturing Oversight: Act as the main Quality liaison with contract manufacturing partners.
* Global Compliance: Ensure comprehensive compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971 (Risk Management) regulations.
* Validation & NPI: Develop, implement, and maintain process validation, equipment qualification, and test method validation.