Quality Operations Engineer — QC, Validation & CAPA

Insulet Corporation; Malaysia; On-site; MYR 60,000 - 100,000; Full time

Job summary

Insulet Corporation in Malaysia seeks an Associate Engineer, Quality Operations to ensure analytical QC functions align with validated processes and cGMP standards. The role supports validation, testing, and reporting across sterile release and environmental monitoring, driving efficient quality outcomes.

Responsibilities include lot qualification, QA testing, CAPA, deviation handling, and documentation updates, with emphasis on process improvement and cross-functional collaboration in a

Qualifications

• Bachelor's degree in science or engineering required.
• Fresh graduate or quality experience in medical devices is acceptable.
• Familiarity with ISO13485 and quality systems preferred.

Responsibilities

• Ensure adoption, compliance and control of analytical functions in QC for validation, testing and reporting of in-process, pre and post-sterile release and environmental monitoring.
• Maintain efficient, cGMP-compliant operations and support quality program activities.
• Complete lot qualification testing to support production release and supply.
• Manage in-process QA testing, environmental monitoring and microbiology testing.
• participate in QA equipment validation activities and set up inspection procedures.
• Handle quality issues, investigation, NCMR, deviation, CAPA and field return within Master Control.
• Review/update Quality documentation (QCP, Manufacturing Instructions) as necessary.
• Track, trend and analyze data and provide routine feedback to Manufacturing, Quality, and Lifecycle Engineering.

Skills

English

Malay

Interpersonal

Communication

Auditor training

ISO13485

Education

Bachelor's degree in science or engineering

Tools

Word

Excel

Outlook

PowerPoint

Job description

Insulet Corporation in Malaysia seeks an Associate Engineer, Quality Operations to ensure analytical QC functions align with validated processes and cGMP standards. The role supports validation, testing, and reporting across sterile release and environmental monitoring, driving efficient quality outcomes.

Responsibilities include lot qualification, QA testing, CAPA, deviation handling, and documentation updates, with emphasis on process improvement and cross-functional collaboration in a