Quality Operations Technician

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

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

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

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

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

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

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

• Conduct and coordinate 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.

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

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

• Generate weekly, monthly and quarterly data analysis reports.

• 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.