Quality Assurance Coordinator I

Insulet Corporation; Malaysia; On-site; MYR 28,000 - 45,000; Full time

Job summary

Insulet Malaysia seeks Inspectors for In-Process QA, Lot Qualification, and Incoming QA inspections to support manufacturing. You will perform QA acceptance activities across inspection stages and document results in the MES/SAP systems, ensuring adherence to GDP and quality standards.

The role requires experience with precision measurement tools, strong attention to detail, and collaboration with leaders to resolve issues while maintaining 5S and safety in the workplace.

Qualifications

• Minimum SPM or equivalent with relevant experience.
• 1-2 years QA/QC inspection experience in visual inspection and precision measurement.
• Experience in medical device industry preferred.
• Proficient in English and Malay.
• Computer literacy, especially Excel.
• Team player with effective communication.
• Accurate and reliable in task performance.

Responsibilities

• Perform inspection, testing and measurement for incoming, in-process, or lot qualification per work instructions.
• Record data in MES/SAP and checklists following Good Documentation Practices.
• Use QC instruments such as measuring scope, CMM, OGP, calipers, and microscope.
• Operate testers like roughness, spring latch, and leak testers.
• Accept or reject outputs per quality standards and report deviations promptly.
• Assist in first-line troubleshooting of QA inspection issues.
• Maintain 5S and safety in the workplace.
• Support quality processes like raising NCMR and MRB responsibilities.

Skills

English language

Malay language

QA/QC inspection

Visual inspection

Precision measurement

MES/SAP

Excel

Team collaboration

Education

SPM or equivalent

Tools

CMM

OGP

Digital calipers

Microscope

Roughness tester

Leak tester

Job description

Job Summary

Job Title: Inspector, In-Process QA Inspection

Inspector, Lot Qualification Inspection

Inspector, Incoming QA Inspection

Department: Quality

Manager/Supervisor: Leader, In-Process QA Inspection

Leader, Lot Qualification Inspection

Leader, Incoming QA Inspection

Position Overview:

The successful candidate will be responsible to perform QA acceptance activities for Incoming QA inspection, In-Process QA inspection and Lot Qualification inspection to support Insulet Malaysia manufacturing.

Responsibilities:

• Perform inspection, testing and measurement for incoming, in-process, or lot qualification according to the work instruction and procedure.
• Generates required document and record data for inspection, test and measurement in system (MES/SAP)/checklist follow Good Documentation Practices
• Handle and use QC dimensional measuring instruments i.e (measuring smart scope, CMM, OGP, digital calipers, microscope and etc).
• Handle and use tester equipment i.e (roughness tester, spring latch tester, leak tester and etc)
• Accept or reject inspection, testing and measurement with respect to quality standards and report any deviations or non-conformances promptly to the leader for immediate action.
• Participates and assists in first level troubleshooting on QA inspection issues and escalates issues when necessary.
• Ensures inspection output meets targeted output without compromising quality.
• Maintain 5S and safety in workplace and equipment.
• Support quality management processes like raising NCMR, handling MRB and other duties when required.

Requirements:

• Minimum SPM or its equivalent with a combination of experience.
• 1 -2 years of on-the-job QA/QC inspection experience in visual inspection, precision measurement instruments, force measurement equipment and product functional testing, preferably in the medical device industry.
• Able to communicate in both English and Malay language.
• Computer literate and competent in Microsoft Excel and data entry skills.
• Team player and ability to communicate effectively with leaders and other employees.
• Able to perform tasks with accuracy and reliability.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!