In-Process Quality Leader

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.