In-Process Quality Leader — Team Coach & Compliance

Insulet; Gelang Patah; On-site; MYR 60,000 - 90,000; Full time

Job summary

Insulet Malaysia is seeking a QA lead to manage and coach a team of QA inspectors involved in In-Process and Lot Qualification inspections to support manufacturing. You will ensure GLP/GDP compliance, maintain inspection records, and drive continuous quality improvements.

The ideal candidate has 2–5 years of QA/QC experience in medical devices, fluent in English and Malay, and strong Excel/data-entry skills. Start-up exposure is a plus, with independent working capability and attention to detail.

Qualifications

• 2–5 years QA/QC inspection experience in medical devices.
• Diploma or equivalent education.
• Proficient in English and Malay.
• Experience in a start-up production environment is a plus.
• Attention to detail and able to work independently with minimal supervision.
• GDP (Good Documentation Practices) knowledge is a plus.
• Familiar with GLP (Good Lab Practices).
• Proficient in Excel and data entry.

Responsibilities

• Lead and coach a team of QA inspectors focusing on performance, behaviors, product quality, and inspection effectiveness.
• Document and report status of In-Process QA and Lot Qualification inspection, shift, daily, weekly and monthly.
• Provide timely performance feedback and deliver annual appraisals.
• Ensure compliance of inspection procedures and GLP to enhance product quality.
• Train and onboard new employees.
• Train QA inspectors on inspection procedures and test equipment skills.
• Ensure inspection output meets targets without compromising quality.
• Perform first level troubleshooting on QA inspection issues and escalate when necessary.
• Support CAPA, NCMR, MRB processes and other duties as required.

Skills

Team leadership

QA inspection

Medical device

GDP/GDP knowledge

GLP knowledge

Excel

Bilingual EN/Malay

Education

Diploma in related field

Tools

Excel

Test equipment

Job description

Insulet Malaysia is seeking a QA lead to manage and coach a team of QA inspectors involved in In-Process and Lot Qualification inspections to support manufacturing. You will ensure GLP/GDP compliance, maintain inspection records, and drive continuous quality improvements.

The ideal candidate has 2–5 years of QA/QC experience in medical devices, fluent in English and Malay, and strong Excel/data-entry skills. Start-up exposure is a plus, with independent working capability and attention to detail.