Quality Engineer II — Medical Device QA & Compliance

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

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