Lead Product Quality Engineer, Medical Devices

SCIEX

Singapore

On-site

SGD 120,000 - 180,000

Full time

5 days ago

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Job summary

SCIEX in Woodlands, Singapore seeks a Senior Engineer, Product Quality to lead PQE for assembly and test operations. You will drive complex quality investigations, risk management, and validation across the product lifecycle, ensuring compliance with QMS and global medical device standards.

This on-site role partners with cross-functional teams to elevate manufacturing quality and regulatory readiness. The ideal candidate holds a Bachelor's in engineering/science and 3–5 years in regulated

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 hands-on quality/risk management.
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 of quality issues.
Champion complex quality investigations (NCMR, CAPA) using structured problem-solving methods.
Drive continuous improvement through quality trends and KPI analysis.
Ensure compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 820 and related standards.