This Post Market Document & Project Coordinator at Insulet is responsible for quality activities to ensure current process requirements are met. Interfaces with other Insulet departments (e.g. Operations, and Information Technology, Engineering, and Regulatory Affairs) as well as other external parties on issues related to product monitoring. Effectively processing documents, coordinating project deliverables, assessing schedule risks and addressing any conflicting requirements are resolved.

Responsibilities: Collaborate with staff to review, approve and overall ensure compliance within QMS documents.Responsible for maintaining and updating departmental documentsLeads projects-creation of schedule, deliverables in collaboration with stakeholdersPrepares and coordinates monthly project metrics -Quality Events, CAPA, deviationsWorks on Global Product Monitoring continuous improvement process globallyCoordinates GPM activities required to support new product launchesParticipates in Global Product Monitoring risk management activities
Perform other duties as requested
Minimum Requirements:Bachelor’s degree.A minimum of 3 years’ experience in a professional role within the medical technology, life sciences, or healthcare setting.

Preferred Skills and Competencies: Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 – Application of risk management to medical devices.At least 3 years experience in a technical and/or quality/compliance discipline/regulated industry.Demonstrated experience organizing and maintaining large documentation sets.Ability to coordinate, maintain, manage and follow up with task owners to close out open items.Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.Knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)Ability to organize and judge priorities. Strong attention to detail with excellent grammatical, editorial, and proofreading skills.Project management skills: timelines, ownership, drive accountability, etc.Experience leading/managing improvement projects.Ability to problem solve / conduct root cause investigations.Periodic travel may be required

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $69,525.00 - $104,287.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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