IPQA Team Lead

1 week ago


Gelang Patah, Johor, Malaysia Insulet Full time 80,000 - 120,000 per year

Position Overview:

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 escalate issues 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.

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