Quality System Specialist (Contract Ends in Dec 2028)

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

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Quality System Specialist for APAC Quality Regional Integration is accountable for supporting the regional leaders in the transition planning for Quality Regional teams at Asia-Pacific region and countries-readiness program.

This person will cover transition and sites readiness activities at multiple locations at ASIA and Pacific region.

• Support the identification and implementation of quality requirements for the 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.

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT),byapplyingtothis role, you will be applying for a position with Waters.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

SGP The Strategy

Additional Locations

JPN Tokyo - Minato-ku

Work Shift