Engineer, Quality Operations

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.

Responsibilities:

Reporting directly to the Manager, Quality Operations, the Engineer, Quality Operations is responsible to ensure adoption, compliance and control of a variety of analytical functions that occur in the QC department supporting validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples. This role also ensures activities occur in an efficient and cGMP compliant manner.

• Ensure the completion of lot qualification testing of production release to maintain customer supply.

• Manage in-process quality assurance testing, environmental monitoring and microbiology testing.

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

• Handling quality issues, performing and involve in failure investigation, NCMR, deviation, CAPA, and field return within the Master Control system.

• Review and update Quality documentation (Quality Control Plan, Manufacturing Instruction & Others) as necessary.

• Track, trend and analyze lot qualification test data (functional, packaging, etc.) and provide routine feedback to Manufacturing, Quality, and Lifecycle Engineering.

• Optimize the pre and post sterilization product testing process as appropriate.

• Drive continuous improvement into the investigational process to yield more efficient and robust processes.

• Enhance quality system processes as it pertains to management of assigned deliverables to ensure compliance.

• Conduct trainings and certification assessments for lot qualification inspectors.

• Develop and/or manage quality programs related to resolution of issues arising from manufacturing operations as well as post manufacturing activities. Provide QA Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions, as it relates to Manufacturing Quality.

• Generate weekly, monthly and quarterly data analysis reports for management visibility.

• Assist or leads CAPA evaluation and closure as related to operations quality processes.

• Support product release initiatives and tasks as needed.

• Participating in external and internal audits.

• Support site during external audits (i.e., BSI, FDA, customer).

• Performs other duties as required.

Requirements

·       Bachelor's degree (preferably science or engineering discipline) required.

·       2 to 4 years of experience in quality in the medical device industry.

·       Fluent in both English and Malay language.

·       Ability to communicate and work effectively at multiple levels within the organization.

·       Good interpersonal skills in dealing with peers and other functional areas.

·       Working knowledge of ISO13485 quality system standard.

·       Auditor training certification to ISO13485 or other industry QMS standard preferred.

·       The ability to prioritize multiple competing deliverables simultaneously.

·       Must be proficient in Word, Excel, Outlook and Power Point.