In-Process Quality Leader

Insulet; Gelang Patah; Sur place; MYR 60 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Team leadership

QA inspection

Medical device

GDP/GDP knowledge

GLP knowledge

Excel

Bilingual EN/Malay

Formation

Diploma in related field

Outils

Excel

Test equipment

Description du poste

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The successful candidate will be responsible for leading a team of QA inspectors in managing the In-Process QA inspection and/or Lot Qualification inspection to support Insulet Malaysia manufacturing.

Responsibilities:

• Manage 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/or Lot Qual inspection, shifty, daily, weekly and monthly.
• Provide timely performance feedback to personnel and responsible for delivering annual performance appraisals.
• Ensure the compliance of inspection procedures and work instructions, effective inspection and Good Lab Practices (GLP) to enhance product quality.
• Ensure timely training and on-boarding of new employees.
• Train and mentor QA inspectors on the QA inspection procedures and test equipment skills.
• Ensures inspection output meets targeted output without compromising quality.
• Perform first level troubleshooting on QA inspection issues and escalation when necessary.
• Support quality management processes like raising NCMR, following up CAPA, managing MRB etc and other duties when required.

Requirements:

• Minimum Diploma in a related field of study or with a combination of education and experience.
• 2 - 5 years of on-the-job QA/QC inspection experience in visual inspection, precision measurement instruments, force measurement equipment and product functional testing, preferably in medical device industry.
• Must be proficient in both English and Malay language.
• Experience in a start-up production environment is a plus.
• Excellent attention to detail, good organization, and capable of working independently with minimal supervision.
• Experience in GDP (Good Documentation Practices) & legible handwriting
• Knowledge of GLP (Good Lab Practices) will be a plus.
• Microsoft Excel and data entry skills.
• Team player and ability to communicate effectively with supervisor and other employees.
• Able to perform tasks with accuracy and reliability.