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.
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!
The Team Lead of Complaint Determination will work under the guidance of the Global Program Manager, Global Product Monitoring and will complete and oversee a team of individuals to ensure compliant complaint determination decisions are made. This person is responsible for executing and leading all aspects of the complaint determination process. They will follow established global regulations and processes for complaint determination.
Responsibilities
- Review and execute the process to determine if an inquiry object meets the definition of a medical device complaint.
- Assign cases, determined to be complaints, with an appropriate category to allow for better assignment at the next phase of the complaint handling process
- Assign cases, containing non complaint feedback, with an appropriate category to allow for better trending and reporting activities
- Reassess inquiry records when new information is received
- Lead, provide guidance, and train a team of individuals executing the complaint determination process
- Provide coaching and feedback to direct reports
- Identify process improvement opportunities to enhance surveillance and to increase efficiency
- Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes Create and update documentation master files
- Performs other complaint handling responsibilities as required
Required Leadership/Interpersonal Skills & Behaviors
- Ability to handle team interpersonal conflicts and find an acceptable resolution.
- Effective verbal communication and excellent technical writing skills
- Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision
- Ability to organize and judge priorities.
- Comfortable communicating to all levels and functions.
- Strong attention to detail.
- Ability to work in a team environment
Required Skills and Competencies
- Solid understanding of QSR and/or ISO 13485.
- Demonstrated knowledge of Microsoft Office
- Working knowledge of complaint handling functions of a medical device company
- Working understanding of TrackWise and SalesForce CRM preferred
- Effective written and verbal communication skills
- Ability to generate and maintain accurate records
Education and Experience
- 3-5 years’ experience in medical device complaint handling, or more than 3 years’ experience within Medical Device Quality Systems and/or equivalent combination of education and experience.
- Prior people leadership experience strongly preferred
Additional Information
- The position can be remote, hybrid, or in-person. If in-person the preferred location is the Acton, Massachusetts facility.
- Travel is estimated at 5% but will flex depending on business needs.
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
The candidate for this role may be employed through a third-party partner of Insulet.
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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What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
