IQA Inspector I

Insulet; Gelang Patah; On-site; MYR 24,000 - 36,000; Full time

Job summary

An established industry player is seeking motivated individuals to join their expanding team. This role involves performing quality assurance inspections and testing to ensure products meet high standards. The successful candidate will utilize precision measurement instruments and contribute to quality management processes in a dynamic environment. If you are a detail-oriented team player with a passion for quality in the medical device industry, this opportunity is perfect for you. Join a company that values innovation and quality, and make a significant impact on the lives of patients through your work.

Qualifications

• 1-2 years of QA/QC inspection experience in the medical device industry.
• Able to communicate in English and Malay, with strong teamwork skills.

Responsibilities

• Perform inspections and testing according to work instructions.
• Generate documents and record data following Good Documentation Practices.
• Handle QC measuring instruments and tester equipment.

Skills

QA/QC inspection

Visual inspection

Precision measurement instruments

Communication skills

Teamwork

Data entry skills

Education

SPM or equivalent

Tools

MES

SAP

Measuring smart scope

CMM

Digital calipers

Microscope

Roughness tester

Spring latch tester

Leak tester

Job description

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!

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:

1. Perform inspection, testing and measurement for incoming, in-process, or lot qualification according to the work instruction and procedure.
2. Generate required documents and record data for inspection, test and measurement in system (MES/SAP)/checklist following Good Documentation Practices.
3. Handle and use QC dimensional measuring instruments (e.g., measuring smart scope, CMM, OGP, digital calipers, microscope, etc.).
4. Handle and use tester equipment (e.g., roughness tester, spring latch tester, leak tester, etc.).
5. 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.
6. Participate and assist in first level troubleshooting on QA inspection issues and escalate issues when necessary.
7. Ensure inspection output meets targeted output without compromising quality.
8. Maintain 5S and safety in workplace and equipment.
9. Support quality management processes like raising NCMR, handling MRB and other duties when required.

Requirements:

1. Minimum SPM or its equivalent with a combination of experience.
2. 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.
3. Able to communicate in both English and Malay language.
4. Computer literate and competent in Microsoft Excel and data entry skills.
5. Team player with the ability to communicate effectively with leaders and other employees.
6. Able to perform tasks with accuracy and reliability.