APAC Quality Systems Lead - Regulatory & Compliance

Becton, Dickinson and Company

Singapore

On-site

SGD 70,000 - 90,000

Full time

2 days ago

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Job summary

Waters Corporation is seeking a Quality System Specialist for APAC Regional Integration to support transition planning for Quality Regional teams across Asia-Pacific and country readiness initiatives. You will oversee site readiness across APAC locations and coordinate with Regulatory Affairs, Supply Chain, Commercial, and Operations to ensure QMS compliance.

Responsibilities include implementing QMS processes per ISO 13485 and ISO 9001, identifying quality agreements with 3PLs and external

Responsibilities

Support identification and implementation of quality requirements for establishment and expansion of global quality presence at APAC region.
Ensure the implementation of Quality Management System (QMS) processes in compliance with applicable regulatory requirements, including QMS certification (ISO 13485, ISO 9001) as appropriate.
Identify when Quality Agreements with Third-Party Logistics providers (3PLs), distributors, and other external partners are required.
Identify when Quality roles are mandatory requirement per country-specific regulations.
Identify requirements and timing for Post-Market Quality at each country.
Coordinate dependencies and communication with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.
Ensure Quality is implemented in compliance with applicable regulations and requirements.
Perform other duties and responsibilities as assigned.