APAC Quality Systems Specialist - ISO & QMS

Becton Dickinson Medical (S) Pte Ltd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Waters is seeking a Quality System Specialist for APAC Regional Integration to support transition planning and country-readiness activities across Asia-Pacific. The role focuses on building a compliant quality presence and coordinating with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.

The incumbent will ensure QMS processes meet regulatory requirements (ISO 13485, ISO 9001) and identify quality agreements with third parties where needed, while supporting site readiness

Qualifications

• Experience in quality/regulatory readiness in APAC.
• Familiarity with QMS ISO 13485 and ISO 9001.
• Ability to coordinate cross-functional teams and manage complex programs.

Responsibilities

• Support transition planning for Quality Regional teams in APAC and countries-readiness program.
• Cover transition and site readiness activities at multiple locations in Asia-Pacific.
• Identify quality requirements for establishment and expansion of global quality presence in APAC.
• Ensure QMS processes comply with regulatory requirements, including ISO 13485 and ISO 9001.
• Identify when Quality Agreements with 3PLs, distributors and external partners are required.
• Identify when Quality roles are mandatory per country regulations.
• Coordinate dependencies and communication with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.
• Ensure Quality implementation complies with applicable regulations and requirements.
• Perform other duties and responsibilities as assigned.

Job description

Waters is seeking a Quality System Specialist for APAC Regional Integration to support transition planning and country-readiness activities across Asia-Pacific. The role focuses on building a compliant quality presence and coordinating with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.

The incumbent will ensure QMS processes meet regulatory requirements (ISO 13485, ISO 9001) and identify quality agreements with third parties where needed, while supporting site readiness