Associate Engineer, Quality Operations

13 hours ago

Gelang Patah, Johor, Malaysia Insulet Full time

Position Overview:

The Associate 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.

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.  Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.

Responsibilities:

· 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.

· Perform and complete root cause investigations within the Master Control system.

· 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 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.

Education and Experience:

Minimum Requirements:

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

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

· Microbiology testing experience will be an advantage.

· 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.

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