Senior Administrator, Quality Assurance

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!

Job Title:Senior Quality Administrator

Department: Quality

Manager/Supervisor: Senior Quality Operations Manager

Position Overview:

The Quality Administrator plays a key role in maintaining the quality management system (QMS) and ensuring compliance with regulatory standards. This position involves overseeing and coordinating quality assurance activities, supporting continuous improvement initiatives, and managing documentation and records. The Quality Administrator is responsible for the following responsibilities:

Responsibilities:

• Responsible for overall quality reporting involving data collection from system Arena/SAP/MES and any electronics and manual records
• Archival and retrieval of the quality documents.
• Work together with Quality engineers and managers to generate and distribute quality metrics performance.
• Assist team prepared for internal and external audit to update quality documentation, including procedures and work instructions.
• Maintain calendar(s), schedule project or group meetings, and manage all meeting details such as room reservations, preparing agendas, securing necessary IT equipment, initializing presentations, catering, and attendee updates for the Quality team.
• Assist in the ordering, receiving, stocking, and distribution of office and quality supplies, materials, and uniforms for the department.
• Reviewing & managing all payroll/OT data for QA department.
• Sourcing supplier and deal with purchasing for quotation and raise purchase requisition in SAP.
• Monitoring and coordinate calibration master list.
• Managing and coordinating travel arrangements, transportation logistics, and itinerary planning for employees and executives of quality department.
• Liaising with trade compliance for custom application and exemption for export and import.
• Perform other duties as required

Requirements

• Minimum Diploma in Admin, Business or Science, or with a combination of education and experience.
• At least 3 years of hands-on experience in handling admin activities in manufacturing environment, preferably in the medical device industry.
• Reasonable understanding of ISO13485 requirements.
• Experience in GDP (Good Documentation Practices) & GMP (Good Manufacturing Practices)
• Microsoft office, data entry and analytical skills. Power BI skill added advantage
• Must be proficient in both English and Malay language.
• Team player and ability to communicate effectively with supervisor and other employees.