Quality Operations Technician

Job Summary

Job Title: Technician, Quality Operations

Department: Quality

Manager/Supervisor: Engineer, Quality Operations

Position Overview:

The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.

Responsibilities:

· Perform lot qualification testing of production release to maintain customer supply.

· Conduct in-process quality assurance testing, environmental monitoring and microbiology testing.

· Perform first level troubleshooting of product inspection/testing issues and escalate issues when necessary.

· Maintain inspection records and ensure data entered the computer and/or MES/SAP system.

· Assist Quality Engineer to optimize the pre and post sterilization product testing process as appropriate.

· Track and trend qualification test data (functional, packaging, etc.) and provide routine feedback to Quality Engineer.

· Participate in continuous improvement into the investigational process to yield more efficient and robust processes.

· Conduct training on usage of tester equipment and assist Quality Engineer on certification assessments for lot qualification inspectors.

· Assist Quality Engineers in handling CAPA, NCMR and MRB.

· Participate in internal or external quality audits, as required.

· Performs other duties as required.

Requirements

· Minimum Diploma in Engineering or Science, or with a combination of education and experience.

· At least 3 years of hands-on experience in quality operation, inspection and testing, preferably in the medical device industry. Microbiology testing experience will be an advantage.

· Experience in test method validation and GR&R will be an advantage.

· Reasonable understanding of ISO13485 requirements.

· Experience in GDP (Good Documentation Practices) & legible handwriting

· Knowledge of GLP (Good Lab Practices) will be a plus.

· Microsoft Excel, data entry and analytical skills.

· Must be proficient in both English and Malay language.

· Team player and ability to communicate effectively with supervisor and other employees.



Job Title:                             Technician, Quality Operations

 

Department:                     Quality

 

Manager/Supervisor:    Senior Engineer, Quality Operations

 

Job Grade:                         3

 

 

 

Position Overview:

The Technician, Quality Operations is responsible for preventive maintenance and calibration program of QA equipment, assisting in Quality Operations activities and coordinating environmental monitoring & microbiology testing. All work to be done in accordance with complying Insulet’s defined Standard Operating Procedures, Work Instructions and Health & Safety requirements at all times.

 

Responsibilities:

1. Maintain, coordinate and conduct preventive maintenance program and calibration program of QA equipment.

2. Review and maintain preventive maintenance records, and calibration records in SAP system.

3. Developing and maintaining test programs used in QA equipment for in-process quality assurance testing.

4. Take part in QA equipment validation activities, set up inspection procedures based on specifications and qualify testing system.

5. Provide and conduct training to Quality Operations team on quality measures and method of using equipment and test programs correctly.

6. Assist the Quality Operations team in lot qualification testing of production release and in-process quality assurance testing.

7. Conduct and coordinate environmental monitoring and microbiology testing.

8. Perform first level troubleshooting of product inspection/testing issues and escalate issues when necessary.

9. Maintain inspection records and ensure data entered the computer and/or MES/SAP system.

Assist Quality Engineer to optimize the pre and post sterilization product testing process as appropriate.  

10. Track and trend qualification test data (functional, packaging, etc.) and provide routine feedback to Quality Engineer.

11. Participate in continuous improvement into the investigational process to yield more efficient and robust processes.

12. Assist Quality Engineer and Team Leader on certification assessments for Quality Operations inspectors.

13. Assist Quality Engineer in handling CAPA, NCMR and MRB.

14. Generate weekly, monthly and quarterly data analysis reports.

15. Participate in internal or external quality audits, as required.

16. Performs other duties as required.

Requirements

·       Minimum Diploma in Engineering or Science, or with a combination of education and experience.

·       At least 3 years of hands-on experience in quality operation, inspection and testing, preferably in

the medical device industry. Microbiology testing experience will be an advantage.

·       Experience in test method validation and GR&R will be an advantage.

·       Reasonable understanding of ISO13485 requirements.

·       Experience in GDP (Good Documentation Practices) & legible handwriting

·       Knowledge of GLP (Good Lab Practices) will be a plus.

·       Microsoft Excel, data entry and analytical skills.

·       Must be proficient in both English and Malay language.

·       Team player and ability to communicate effectively with supervisor and other employees.

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.