Regulatory QA Engineer - Medical Devices & Quality Systems

BECTON DICKINSON MEDICAL (S) PTE LTD; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive compensation package

Paid holidays

Career development opportunities

Transit provided

Zusammenfassung

BECTON DICKINSON MEDICAL (S) PTE LTD is seeking a Quality Assurance Engineer to support product development and quality system activities in a regulated medical device environment in Singapore. You will ensure compliance with ISO 13485, FDA QSR, and international requirements while supporting design controls, risk management, and continuous quality improvement.

You will work with cross‑functional teams across the product lifecycle to embed quality into every stage of development, participate in

Qualifikationen

• Bachelor's degree in a related engineering or quality field.
• Minimum 2 years in a quality role in a medical device company.
• Experience in an R&D Phase‑Gate development or design transfer process.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QSR.
• Familiar with Design Controls, Verification & Validation, and Risk Management (ISO 14971).
• Experience with quality documentation, SOP development, change control, and document management systems.

Aufgaben

• Support and maintain Design and Development Controls in ISO 13485 and FDA QSR compliance.
• Lead or support Risk Management activities per ISO 14971.
• Participate in product development projects ensuring QA deliverables on time.
• Create, revise, and maintain controlled quality documentation (SOPs, specs, procedures, test methods).
• Ensure compliance of R&D and quality processes with regulatory and customer requirements.
• Support continuous improvement to strengthen quality system effectiveness.
• Provide quality system expertise and training to cross‑functional teams.
• Collaborate with engineering, manufacturing, regulatory, and project teams for lifecycle management.

Kenntnisse

Problem solving

Analytical skills

Communication skills

Quality mindset

Cross-functional collaboration

Ausbildung

Bachelor's degree in Mechanical Engineering, Life Sciences, Quality, Biomedical Engineering, or related

Tools

SOP development

Document management systems

Change control

Risk assessment tools

Jobbeschreibung

BECTON DICKINSON MEDICAL (S) PTE LTD is seeking a Quality Assurance Engineer to support product development and quality system activities in a regulated medical device environment in Singapore. You will ensure compliance with ISO 13485, FDA QSR, and international requirements while supporting design controls, risk management, and continuous quality improvement.

You will work with cross‑functional teams across the product lifecycle to embed quality into every stage of development, participate in