Quality Engineer II

BECTON DICKINSON MEDICAL (S) PTE LTD; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive full‑time compensation

Paid company holidays

Career development opportunities

Convenient company transportation

Job summary

Becton Dickinson Medical (S) PTE LTD in Singapore is seeking a Quality Assurance Engineer to uphold stringent medical device quality systems across the product lifecycle. You will implement design controls, risk management, and regulatory compliance in a regulated environment.

You will collaborate with engineering, regulatory, and manufacturing teams to ensure Quality Assurance deliverables are met on time, with emphasis on ISO 13485, FDA QSR, and ongoing process improvement using Six Sigma

Qualifications

• Minimum 2 years' quality experience in a medical device company.
• Experience with R&D Phase-Gate development or design transfer processes.
• Strong knowledge of ISO 13485 and FDA QSR 21 CFR Part 820.

Responsibilities

• Support and maintain Design and Development Controls in ISO 13485 and FDA QSR.
• Lead or support Risk Management activities per ISO 14971.
• Participate in product development projects ensuring QA deliverables are completed on time.

Skills

Quality Assurance

Regulatory knowledge

Analytical thinking

Communication skills

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering Life Sciences Quality Biomedical Engineering

Tools

SOP development

Change control

Document management systems

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 Part820/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