Job Description

Job Title:                             Quality Technician

Department:                     7400 - QA Quality Assurance

FLSA Status:                      Non-Exempt

Position Overview:
The Post Market Quality Technician plays an integral role in Insulet’s Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. 

Responsibilities:

Perform moderately complex tasks to ensure compliance with quality standardsPartner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintainedGenerate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPAPerform product testing and failure analysisReview Lot Acceptance records and DHRsCollect log quality data and trend resultsAccountability for quality data entry and productivityAssist in gathering information during FDA and ISO 13485 inspectionsTrouble shoot new failure modes.Evaluate process and engineering controls to improve safety and efficiency.Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

Associates Degree in an engineering, or scientific discipline

Preferred Skills and Competencies:

Electrical and mechanical background strongly preferredPrior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferredPreferred 2 years in a Quality related function, working with QSR and/or ISO 13485Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plusAbility to organize and complete tasks with minimal supervisionExcellent technical writing skillsExcels at generating and maintaining organized and accurate recordsExperience with Lean Six Sigma methodology a plus

Physical Requirements (if applicable):          

Sitting 70%, Standing 30%Frequent lifting <5lbsOccasional (<10% of time) handling (push/pull) up to 50lbsAbility to operate basic hand tools

NOTE: This position requires on-site working arrangements (requires on-site office/plant/lab work). #LI-onsite

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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