QA Engineer – MedTech Quality & Process Improvement

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

Benefits offered by this job

Competitive compensation

Paid holidays

Career development

Transportation provided

Job summary

BD in Singapore is seeking a Quality Engineer to oversee product quality from assembly to packaging, ensuring compliance with quality systems and regulatory requirements. You will drive data-driven investigations of non-conformances, CAPA, deviations, and support audits.

Ideal candidates have 1–2 years in quality engineering, knowledge of CFR Part 820 and ISO 13485, and a Six Sigma Green Belt certification. You will collaborate with R&D and operations to deliver robust quality improvements.

Qualifications

• 1-2 years of relevant experience in quality engineering.
• Understanding of Quality Management Systems, CFR Part 820, ISO 13485.
• Six Sigma Green Belt certification or knowledge of Six Sigma tools.
• Ability to multi-task and work independently with initiative.

Responsibilities

• Oversee product quality from assembly to packaging and ensure compliance with quality system and regulation requirements.
• Lead data-driven investigations of non-conformances, complaints, CAPA, deviations and other quality matters.
• Coordinate with R&D and quality teams to meet product specs and quality requirements.
• Drive quality improvement and automation projects with planning, inspections, testing and reporting.
• Perform test method validation, installation qualification and correlation studies for new quality equipment/methods.
• Support audits and lead corrective actions with internal, external and supplier sources.
• Analyze data and trending for product quality during monthly/quarterly reviews.
• Maintain controlled manufacturing and engineering documentation per regulatory requirements.
• Supervise quality technicians and specialists on tests and checks.
• Promote safety and ISO 14001 environmental accountability in the workplace.
• Perform any other tasks as assigned.

Skills

Quality engineering

Data analysis

Regulatory compliance

Six Sigma Green Belt

ISO 13485 knowledge

Job description

BD in Singapore is seeking a Quality Engineer to oversee product quality from assembly to packaging, ensuring compliance with quality systems and regulatory requirements. You will drive data-driven investigations of non-conformances, CAPA, deviations, and support audits.

Ideal candidates have 1–2 years in quality engineering, knowledge of CFR Part 820 and ISO 13485, and a Six Sigma Green Belt certification. You will collaborate with R&D and operations to deliver robust quality improvements.