Quality Engineer II

BD; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Healthcare benefits

Career development opportunities

Transportation provided

Job summary

BD is seeking a Quality Assurance Engineer to support product development and quality system activities within a regulated medical device environment in Singapore.

You will ensure compliance with ISO 13485, FDA QSR, and international requirements while collaborating with cross-functional teams to build quality and lifecycle management into the process.

Qualifications

• Bachelor’s degree in a related discipline.
• Minimum 2 years in a quality role in a medical device company.
• Experience in a R&D Phase-Gate development process and/or design transfer process.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QSR, and medical device quality system requirements.
• Working knowledge of Design Controls, Verification & Validation, and Risk Management (ISO 14971).
• Experience with quality documentation, SOP development, change control, and document management systems.
• Familiarity with Six Sigma, continuous improvement methodologies, or quality tools is advantageous.
• Strong problem-solving, analytical, and communication skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities.
• Experience supporting audits, regulatory inspections, and compliance activities is preferred.

Responsibilities

• Support and maintain Design and Development Controls in compliance with ISO 13485 and FDA Quality System Regulations.
• Lead or support Risk Management activities in accordance with ISO 14971.
• Participate in product development projects, ensuring quality assurance deliverables are completed accurately and on time.
• Create, revise, and maintain controlled quality documentation, including SOPs, specifications, procedures, and test methods.
• Ensure compliance of R&D and quality system processes with applicable regulatory and customer requirements.
• Support continuous improvement initiatives to strengthen quality system effectiveness and operational excellence.
• Apply Six Sigma methodologies and quality tools to improve product development processes.
• Provide quality system expertise and training to cross-functional teams.
• Participate in ongoing Quality Assurance and Quality Systems activities, audits, and compliance initiatives.
• Collaborate with engineering, manufacturing, regulatory, and project teams to ensure successful product development and lifecycle management.

Skills

QA in medical devices

Design Controls

Risk Management (ISO 14971)

Regulatory compliance

Documentation management

Six Sigma

Audit support

Cross-functional collaboration

Education

Bachelor’s Degree in Mechanical Engineering, Life Sciences, Quality, Biomedical Engineering, or related

Job description

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

About the Role

We are looking for a Quality Assurance Engineer to support product development and quality system activities within a regulated medical device environment.

In this role, you will ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and international regulatory requirements while supporting design control, risk management, and continuous quality improvement initiatives.

You will work closely with cross-functional teams throughout the product development lifecycle to ensure quality and compliance are built into every stage of the process. This role aligns with BD’s focus on maintaining robust quality systems, design controls, and regulatory compliance.

What You’ll Do

• Support and maintain Design and Development Controls in compliance with ISO 13485 and FDA Quality System Regulations.
• Lead or support Risk Management activities in accordance with ISO 14971.
• Participate in product development projects, ensuring quality assurance deliverables are completed accurately and on time.
• Create, revise, and maintain controlled quality documentation, including SOPs, specifications, procedures, and test methods.
• Ensure compliance of R&D and quality system processes with applicable regulatory and customer requirements.
• Support continuous improvement initiatives to strengthen quality system effectiveness and operational excellence.
• Apply Six Sigma methodologies and quality tools to improve product development processes.
• Provide quality system expertise and training to cross-functional teams.
• Participate in ongoing Quality Assurance and Quality Systems activities, audits, and compliance initiatives.
• Collaborate with engineering, manufacturing, regulatory, and project teams to ensure successful product development and lifecycle management.

Job Requirements

• Bachelor’s Degree in Mechanical Engineering, Life Sciences, Quality, Biomedical Engineering, or a related discipline.
• Minimum 2 years relevant experience in a quality role in a medical device company
• Experience in a R&D Phase-Gate development process and/or design transfer process
• Experience in Quality Assurance, Design Quality, Quality Systems, or regulated product development environments.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QSR, and medical device quality system requirements.
• Working knowledge of Design Controls, Verification & Validation, and Risk Management (ISO 14971).
• Experience with quality documentation, SOP development, change control, and document management systems.
• Familiarity with Six Sigma, continuous improvement methodologies, or quality tools is advantageous.
• Strong problem-solving, analytical, and communication skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities.
• Experience supporting audits, regulatory inspections, and compliance activities is preferred.

What’s In It For You

• Competitive full‑time compensation package and benefits
• Paid company holidays (public holidays, rest days, etc.)
• Opportunities for career development and growth
• Convenient company transportation provided

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.

Primary Work Location

SGP Tuas - Tuas