Quality Specialist

• Support regional leaders in transition planning for Quality Regional teams across Asia-Pacific countries
• Perform transition and site-readiness activities at multiple locations in Asia and the Pacific region
• Support identification and implementation of quality requirements for establishing and expanding global quality presence in APAC
• Implement Quality Management System processes in compliance with applicable regulatory requirements
• Support QMS certification, including ISO 13485 and ISO 9001, as appropriate
• Identify when Quality Agreements are required with third-party logistics providers, distributors, and other external partners
• Identify mandatory Quality roles under country-specific regulations
• Identify Post-Market Quality requirements and timing for each country
• Coordinate dependencies and communication with Regulatory Affairs, Supply Chain, Commercial, and Operations teams
• Perform other assigned duties and responsibilities

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