Position Overview:
The Quality Assurance Associate will be integral in controlling inspection of incoming materials to support Insulet European lab and perform rework activities. Incoming/rework Inspector must be able to deal with changing priorities. Quality Assurance Associate will inspect incoming material for material order nonstock, incoming QC lots and receiving complaints. Rework activities will be performed for Lot qualification lab.

Responsibilities:

Perform moderately complex tasks to ensure compliance with quality standards.Perform moderate complex lot qualification testing.Inspect nonstock material, transfer them to the location, monitor disposable stock and install ad hoc tooling as requested.Perform rework activities following the instructions.Perform office manager-related activities such as issuing orders, contact suppliers, ordering disposables, etc.Arrange shipments from Insulet facility.Register RMA (complaints) and perform moderate complex tasks.Generate, and maintain Quality records in support of the Quality System.Assist in gathering information during FDA and ISO 13485 inspections.Support lean management on site.Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

High school degree in an engineering or scientific discipline

Preferred Skills and Competencies:

Computer proficiency in MS office (specifically Excel)Electrical and mechanical background preferredKnowledge of Lean preferred.Prior experience working in a regulated industry (medical device) and/or experience working in a biohazard/lab environment preferredSome experience in a Quality related function, working with QMS and/or ISO 13485 preferredGood communication skills.Excels at generating and maintaining organized and accurate records.

Physical Requirements (if applicable):          

Sitting 50%, Standing 50%Frequent lifting <10kgOccasional (<5% of time) handling (push/pull) up to 25kgAbility to operate basic hand tools

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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