Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title: Quality Investigation Material Processor

FLSA Status: Non-Exempt

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

The Quality Investigation Material Processor plays an integral role in Insulet’s Quality Department by taking a hands-on role related to post market investigations of FDA approved medical devices. The role requires strong organizational skills, attention to detail, and the ability to work in cross functional teams to accomplish departmental and company goals.

Responsibilities

§ Perform receipt and unpacking of biohazard materials in safe manner

§ Process and receive in material for complaint investigations

§ Perform product downloads

§ Perform visual inspections of returned product

§ Update, contribute or create procedures/documentation to support quality processes

§ Perform moderately complex tasks to ensure compliance with quality standards

§ Accountability for quality data entry and productivity

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

§ Evaluate process and engineering controls to improve safety and efficiency

§ Perform other duties as assigned

Preferred Skills and Competencies

§ Prior experience working in a regulated industry (medical device) and/or experience working in a biohazard/lab environment preferred

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

§ Computer proficiency in MS office and willingness to learn online software platforms/tools for necessary job functions

§ Ability to organize and complete tasks with minimal supervision

§ Excels at generating and maintaining organized accurate records

Education and Experience

Minimum Requirements:

§ Associates degree in quality, engineering, scientific discipline, or equivalent experience

Additional Information

§ The position is on-site.

§ Physical Requirements:

o Sitting 60%, Standing 40%

o Frequent lifting <5lbs

o Occasional (<10% of time) handling (push/pull) up to 50lbs

o Ability to operate basic hand tools

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

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