Strategic Supplier Quality Engineer (Medical Devices)

Insulet Corporation

Malaysia

On-site

MYR 90,000 - 150,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Insulet Corporation in Malaysia is seeking an Engineer, Supplier Quality to support supplier selection, qualification, and ongoing management to ensure products meet Insulet quality standards. The role interfaces with internal teams and suppliers to communicate metrics and drive continuous improvement.

The position requires a Bachelor’s in engineering or science and 2–5 years in medical device quality, with fluency in English and Malay.

Qualifications

BS degree in engineering/science or equivalent experience.
2–5 years of quality assurance experience in a regulated medical device environment (FDA/ISO).
Experience with Design Control and related documentation.
Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971; EN 60601/ISO 62304 is preferred.
Auditor training certification to ISO 13485/17025 or equivalent preferred.

Responsibilities

Support selection, qualification, and management of suppliers.
Assist qualification of new suppliers, components, and changes with cross‑functional plans.
Maintain supplier audit reports and supplier profile records.
Develop supplier audit schedule and execute scheduled audits.
Prepare audit reports and communicate quality issues to suppliers for corrective actions.
Track supplier performance via scorecards and CAPA follow‑ups.
Support site during external audits (BSI, FDA, Customer).
Participate in training and other duties as assigned.
Oversee Design Control to ensure regulatory and quality compliance for current and new products.