Senior Quality Engineer, Medical Devices & Compliance

Danaher; Singapore; On-site; SGD 90,000 - 140,000; Full time

Benefits offered by this job

Health care program

Paid time off

Job summary

SCIEX, a Danaher operating company in Singapore, seeks a Senior Engineer, Product Quality to lead PQE for assembly and test operations on-site. You will drive quality investigations, risk management, and validation activities across the product lifecycle, ensuring regulatory compliance and continuous improvement.

Ideal candidates have 3–5 years in regulated environments with expertise in risk-based methodologies, PFMEA, and QMS alignment to ISO 9001/13485 and FDA requirements.

Qualifications

• Bachelor's degree in scientific or engineering discipline from a four-year college or university.
• Minimum 3-5 years of experience in regulated environments with risk management and quality systems.
• Exposure to verification and validation of Medical Devices in New Product Introductions.

Responsibilities

• Serve as PQE lead for assembly and test operations, ensuring timely reporting and escalation.
• Lead complex quality investigations (NCMR, CAPA, post-market escalations) with cross-functional teams.
• Drive continuous improvement through quality trends, KPI analysis, and risk-based decisions.
• Develop and maintain Risk Management Files, PFMEA, PCP, IQ/OQ/PQ along lifecycle.
• Ensure compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements.

Skills

Quality problem solving

Cross-functional collaboration

Data-driven analysis

Regulatory awareness

Communication skills

Education

Bachelor's degree in a scientific or engineering discipline

Job description

SCIEX, a Danaher operating company in Singapore, seeks a Senior Engineer, Product Quality to lead PQE for assembly and test operations on-site. You will drive quality investigations, risk management, and validation activities across the product lifecycle, ensuring regulatory compliance and continuous improvement.

Ideal candidates have 3–5 years in regulated environments with expertise in risk-based methodologies, PFMEA, and QMS alignment to ISO 9001/13485 and FDA requirements.