Quality Technician

Job Summary

The Post Market Quality Associate plays an integral role in Insulet’s Quality Department by taking a hands-on technical role related to post market investigations of FDA approved medical devices. The role requires strong organization skills, attention to detail, ability to work in cross functional teams and accomplish of departmental and company goal

Responsibilities:

Perform moderately complex tasks to ensure compliance with quality standards.

• Determine if materials meet requirements for investigation.

Execute initials inspection for received material.

Extract data from returned materials.

Work with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.

Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.

Review Lot Acceptance records and DHRs.

Perform data logging of quality data and trend results.

Accountability for quality data entry and productivity.

Assist in gathering information during FDA and ISO 13485 inspections.

Perform investigation triage leading to trend analysis supporting existing investigations and CAPA.

Evaluate process and engineering controls to improve safety and efficiency

Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

MBO or Associates Degree in an engineering, or scientific discipline

Preferred Skills and Competencies:

Electrical and mechanical background preferred.

Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred.

Preferred 2 years in a Quality related function working with QSR and/or ISO 13485.

Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus.

Excellent technical writing skills.

Ability to organize and complete tasks with minimal supervision.

Excels at generating and maintaining organized accurate records.

Physical Requirements (if applicable):

Sitting 70%, Standing 30%

Frequent lifting <5kg

Occasional (<10% of time) handling (push/pull) up to 23kg

Ability 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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