Quality Assurance Coordinator II

Job Summary

This position will be integral in controlling the inspection of incoming materials to support Insulet's development and manufacturing areas. Must be able to deal with changing priorities. Will inspect incoming and in process sub-assemblies to Insulet quality documentation.

Responsibilities:
• Perform functional testing of devices as it pertains to lot qualification
• Perform package integrity testing of devices as procedurally required
• Mechanical inspection of incoming components and materials.
• Maintain and file inspection records and reports.
• Data input into the Insulet computer system.
• Assist Quality Engineers in development of test methods and device investigations
• Conduct internal quality audits, as required.
• Monitor calibration contractors while testing equipment at Insulet.
• Knowledge of basic shop math is essential.
• Experience with FDA and ISO inspections documentation & standards.
• Performs other duties as required.

Education and Experience:
Minimum Requirements:
• High School degree
• Minimum of 2 years as a mechanical inspector in the Medical Device Industry
Preferred Skills and Competencies:
• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• PC skill, word processing, spreadsheet, database.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
Physical Requirements:
• Ability to lift up to 10 pounds.

Responsibilities:
• Perform functional testing of devices as it pertains to lot qualification
• Perform package integrity testing of devices as procedurally required
• Mechanical inspection of incoming components and materials.
• Maintain and file inspection records and reports.
• Data input into the Insulet computer system.
• Assist Quality Engineers in development of test methods and device investigations
• Conduct internal quality audits, as required.
• Monitor calibration contractors while testing equipment at Insulet.
• Knowledge of basic shop math is essential.
• Experience with FDA and ISO inspections documentation & standards.
• Performs other duties as required.

Education and Experience:
• High School degree
• Minimum of 2 years as a mechanical inspector in the Medical Device Industry
Preferred Skills and Competencies:
• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• PC skill, word processing, spreadsheet, database.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.

Physical Requirements:
• Ability to lift up to 10 pounds.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

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