Audit Associate jobs in Malaysia
IPQA Inspector
Job summary
A leading medical device company in Gelang Patah, Malaysia is seeking a QA Inspector to perform quality control inspections and ensure compliance with standards. The ideal candidate has 1-2 years of experience in QA/QC inspection within the medical device industry, is detail-oriented, and can communicate in both English and Malay. This role offers an opportunity to contribute to quality management processes and ensure high standards in production.
Qualifications
- Minimum 1-2 years of QA/QC inspection experience in the medical device industry.
- Able to perform tasks with accuracy and reliability.
- Team player who can communicate effectively.
Responsibilities
- Perform inspection and testing for incoming and in-process quality control.
- Generate required documents and maintain records following Good Documentation Practices.
- Conduct first level troubleshooting on QA inspection issues.
Skills
Education
Tools
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:
- 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 escalate 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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.