Quality Operations Technician

1 week ago

Gelang Patah, Johor, Malaysia Insulet Full time 43,000 - 86,000 per year

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.

  • Technician, Quality Operations

    1 week ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time 30,000 - 50,000 per year

    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...

  • Supplier Quality Technician

    3 days ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time

    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...

  • Quality Operations Supervisor

    1 week ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time 60,000 - 120,000 per year

    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...

  • Maintenance Technician

    5 days ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time 30,000 - 60,000 per year

    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...

  • Maintenance Technician

    5 days ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time $40,000 - $70,000 per year

    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...

  • Programming Technician

    1 week ago

    Gelang Patah, Johor, Malaysia Agensi Pekerjaan Well Growing Sdn Bhd Full time 25,000 - 27,800 per year

    Pay: RM2, RM2,900.00 per monthJob description:Programming Technician supports production operations by performing machine repair, preventive maintenance, and basic system troubleshooting. The role is responsible for maintaining accurate technical data and documentation, assisting the Senior Engineer with First Article setups, and identifying...

  • Document Coordinator, Quality Operations

    1 week ago

    Gelang Patah, Johor, Malaysia Insulet Full time 30,000 - 60,000 per year

    Position Overview:The Document Coordinator, Quality Operations is responsible for all aspects of Quality Operations Device History Record (DHR) and Quality Records administration. All work to be done in accordance with complying Insulet's defined Standard Operating Procedures, Work Instructions and Health & Safety requirements at all...

  • Technician II, Molding Production

    1 week ago

    Gelang Patah, Johor, Malaysia Alcon Johor (known as CIBA VISION Johor Sdn. Bhd.) Full time 40,000 - 60,000 per year

    Technician II, Molding ProductionAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an...

  • Test Technician

    1 week ago

    Gelang Patah, Johor, Malaysia Insulet Corporation Full time 40,000 - 80,000 per year

    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...

  • Production Technician

    1 day ago

    Gelang Patah, Johor, Malaysia JB Cocoa Sdn Bhd Full time

    We are looking for Production Technician to join our Powder section, to be responsible for supporting daily operations by assisting in the preparation, handling, and processing of powder materials, including maintaining cleanliness and orderliness in the work area, following safety and quality protocols, and assisting machine operators or supervisors as...