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6 дней назад

Team Lead, IPQA (Medical Devices)

Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Malaysia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Team Lead, IPQA (Medical Devices): Leading in-process QA and lot qualification inspections for Insulet's Malaysia manufacturing operations with an accent on inspector coaching, inspection effectiveness, and product quality. Focus on ensuring compliance with inspection procedures, training QA personnel, troubleshooting inspection issues, and supporting CAPA, NCMR, and MRB processes.

Location: Gelang Patah, Johor, Malaysia

Company

hirify.global develops the Omnipod wearable, waterproof, and lifestyle-oriented product platform to support healthier lives for people with diabetes.

What you will do

  • Lead, coach, and evaluate a team of QA inspectors responsible for in-process and lot qualification inspections.
  • Monitor and report inspection status and performance on shift, daily, weekly, and monthly schedules.
  • Ensure compliance with inspection procedures, work instructions, Good Laboratory Practices, and quality targets.
  • Train and mentor inspectors on QA procedures, test equipment, and onboarding requirements.
  • Perform first-level troubleshooting of inspection issues and escalate problems when needed.
  • Support quality processes including NCMR, CAPA follow-up, and MRB management.

Requirements

  • Diploma in a related field or an equivalent combination of education and experience.
  • 2–5 years of QA/QC inspection experience, including visual inspection, precision and force measurement, and product functional testing.
  • Proficiency in both English and Malay is required.
  • Experience with Good Documentation Practices, legible handwriting, Microsoft Excel, and data entry.
  • Strong attention to detail, organization, accuracy, reliability, and ability to work independently with minimal supervision.
  • Effective communication skills and ability to work collaboratively with supervisors and employees.

Nice to have

  • Experience in the medical device industry.
  • Experience in a start-up production environment.
  • Knowledge of Good Laboratory Practices.

Culture & Benefits

  • Full-time position within the Quality department.
  • Performance-driven environment focused on product quality and customer expectations.
  • Opportunity to support manufacturing of wearable and waterproof medical technology.

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