Senior Product Quality Engineer – Life Sciences

AB SCIEX PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

AB SCIEX PTE. LTD. in Singapore seeks a Senior Engineer, Product Quality to lead PQE for assembly/test operations on site. You will drive quality investigations, risk management, and continuous improvement across the product lifecycle in a regulated medical device environment.

You will ensure compliance with ISO 9001/13485, FDA 21 CFR Part 820, and MDSAP, while coordinating with cross-functional teams to deliver robust product quality and manufacturing performance.

Qualifications

• Bachelor's degree in scientific or engineering discipline.
• 3–5 years of experience in regulated environments with medical device risk management.
• Exposure to verification and validation of Medical Devices in New Product Introductions.

Responsibilities

• Serve as PQE lead for assembly/test operations to resolve quality issues.
• Lead quality investigations (NCMR, CAPA, Post Market) with cross-functional teams.
• Improve processes using quality trends and KPI data.
• Maintain Risk Management Files, PFMEA, PCP, and IQ/OQ/PQ validations.
• Ensure compliance with ISO 9001/13485, FDA 21 CFR Part 820 and MDSAP.

Skills

PQE leadership

Quality investigations

CAPA

Root cause analysis

Risk management

Regulatory compliance

Process validation

Cross-functional collaboration

ISO 13485

Education

Bachelor's degree in engineering/science

Tools

PFMEA

Control Plans

IQ/OQ/PQ

Job description

AB SCIEX PTE. LTD. in Singapore seeks a Senior Engineer, Product Quality to lead PQE for assembly/test operations on site. You will drive quality investigations, risk management, and continuous improvement across the product lifecycle in a regulated medical device environment.

You will ensure compliance with ISO 9001/13485, FDA 21 CFR Part 820, and MDSAP, while coordinating with cross-functional teams to deliver robust product quality and manufacturing performance.