Quality Operations Engineer — QC & Validation

Insulet Corporation; Malaysia; Hybrid; MYR 60,000 - 90,000; Full time

Job summary

Insulet Corporation in Malaysia is seeking an Associate Engineer, Quality Operations to support validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples. You will help ensure activities are conducted in a compliant, efficient, and cGMP environment.

The role requires a Bachelor's degree in science or engineering; fresh graduates or candidates with quality experience in the medical device industry are welcome.

Qualifications

• Bachelor's degree in science or engineering required.
• Fresh grad or with quality in medical device industry experience encouraged.
• Fluency in English and Malay, good documentation and communication skills.
• Familiarity with ISO13485 and GMP quality systems preferred.

Responsibilities

• Ensure adoption and control of analytical functions in QC supporting validation and testing.
• Review quality documentation and track lot qualification data for manufacturing.
• Support CAPA, deviation handling, and internal/external audits.

Skills

Quality Assurance

cGMP compliance

Data analysis

QA testing

Documentation

English

Malay language

Education

Bachelor's Degree in Science or Engineering

Tools

MS Excel

MS Word

PowerPoint

Job description

Insulet Corporation in Malaysia is seeking an Associate Engineer, Quality Operations to support validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples. You will help ensure activities are conducted in a compliant, efficient, and cGMP environment.

The role requires a Bachelor's degree in science or engineering; fresh graduates or candidates with quality experience in the medical device industry are welcome.