Senior Product Quality Engineer, Medical Devices

Radiometer; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

SCIEX in Singapore is seeking a Senior Engineer, Product Quality to lead PQE for assembly and test operations, driving timely resolution of product quality issues and ensuring QMS compliance. You will lead complex investigations (NCMR, CAPA) and risk assessments, applying structured problem solving and data-driven improvements across the product lifecycle.

This on-site role reports to the Senior Manager, PQE at the Woodlands site, collaborating across functional teams to meet global quality

Qualifications

• Bachelor's degree in scientific or engineering discipline.
• Minimum 3-5 years in regulated environments with medical device risk management experience.
• Exposure to verification/validation of Medical Devices in NPD.

Responsibilities

• Serve as PQE lead for assembly and test operations; ensure timely reporting and escalation of quality issues.
• Lead complex quality investigations (NCMR, CAPA, post-market) using structured problem-solving.
• Drive continuous improvement via quality trend analysis, KPI review, and risk-based decision-making.
• Ensure compliance with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 in manufacturing.
• Collaborate across functions to improve product quality and regulatory compliance.

Skills

Quality leadership

Risk management

Cross-functional collaboration

CAPA

NCMR

Data analysis

Education

Bachelor's degree in engineering

Job description

SCIEX in Singapore is seeking a Senior Engineer, Product Quality to lead PQE for assembly and test operations, driving timely resolution of product quality issues and ensuring QMS compliance. You will lead complex investigations (NCMR, CAPA) and risk assessments, applying structured problem solving and data-driven improvements across the product lifecycle.

This on-site role reports to the Senior Manager, PQE at the Woodlands site, collaborating across functional teams to meet global quality