Quality Operations Supervisor — Medical Device QA

Insulet Corporation; Johor Bahru; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive Package and Benefits

Career Growth and Development Opportun

Exciting Opportunities to join US Med

Job summary

Insulet Corporation is the global leader in tubeless insulin pump technology with its Omnipod brand of products. We develop, manufacture, and sell our proprietary Omnipod continuous insulin delivery systems for people with diabetes.

The role supports QC, validation, testing, and environmental monitoring in a fast-paced manufacturing environment. The Quality Operations Supervisor role reports to the Manager, Quality Operations and focuses on ensuring cGMP compliance, effective data analysis, and

Qualifications

• Bachelor's degree in science or engineering.
• 2–4 years quality experience in the medical device industry.
• Fluent in English and Malay.
• ISO13485 knowledge and quality systems.
• Auditor training certification to ISO13485 preferred.
• Proficient in MS Word, Excel, Outlook and PowerPoint.
• Ability to prioritize multiple deliverables.

Responsibilities

• Ensure adoption, compliance and control of analytical functions in QC supporting validation, testing and release.
• Manage in-process QA testing, environmental monitoring and microbiology testing.
• Lead CAPA, NCMR, deviations and field returns within Master Control system.
• Review and update Quality documentation (QCP, Manufacturing Instructions, etc.).
• Generate weekly, monthly and quarterly data analysis reports for management.
• Support product release initiatives and participate in audits.

Skills

Multilevel communication

Interpersonal skills

English & Malay fluency

Problem solving

Communication skills

Education

Bachelor's degree in science or engineering

Tools

Word

Excel

Outlook

PowerPoint

Job description

Insulet Corporation is the global leader in tubeless insulin pump technology with its Omnipod brand of products. We develop, manufacture, and sell our proprietary Omnipod continuous insulin delivery systems for people with diabetes.

The role supports QC, validation, testing, and environmental monitoring in a fast-paced manufacturing environment. The Quality Operations Supervisor role reports to the Manager, Quality Operations and focuses on ensuring cGMP compliance, effective data analysis, and