About this role
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!
Position Overview:
The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Incoming Quality Assurance supervisor, as well as leading and managing inspections activities in accordance of FDA approved medical devices. The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.
As an Incoming Quality Supervisor includes overseeing all aspects of quality control for materials entering a facility. They manage a team of inspectors to ensure that raw materials, components, and other goods meet specified standards before being used in production
Responsibilities:
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Team leadership and supervision
Supervise, mentor, and provide day-to-day direction for the incoming quality control (IQC) inspection team.
Develop training plans and conduct training sessions for technicians on inspection procedures, quality standards, and safety.
Create and distribute work assignments and testing priorities to ensure an efficient workflow.
Monitor team performance against key performance indicators (KPIs), such as non-conformance rates and inspection throughput.
Arrange and manage resources to ensure efficiency of the inspection are continuous on time.
Inspection and quality assurance
Execute and implement IQC procedures, test plans, and sampling techniques.
Inspect and approve incoming materials and components for compliance with specifications, using tools like calipers, micrometers, and CMMs (Coordinate Measuring Machines, Smartscope eg. OGP, etc).
Review inspection documentation for accuracy and compliance with quality protocols.
Perform lots acceptance in system upon pass inspection
Ensure that all inspection equipment is properly maintained and calibrated.
Problem-solving and continuous improvement
Manage the process for handling non-conforming materials, from quarantine to disposition.
Lead or participate in root-cause investigations for quality issues found in incoming materials.
Interface with supplier quality engineers to manage and resolve quality problems and implement corrective and preventive actions (CAPAs).
Analyze inspection data to identify trends and recommend improvements to internal processes or supplier quality.
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Documentation and compliance
Maintain accurate and detailed records of all inspection activities and results.
Prepare and present reports on quality metrics and inspection performance for management and other departments.
Ensure the IQC department operates in compliance with internal policies, industry regulations, and quality management systems like ISO 13485.
Participate in internal gemba walk and external audits to ensure compliance.
Publish and reporting quality inspection data and performance.
Communication and collaboration
Act as the primary point of contact for internal stakeholders relate to incoming activities, such as engineering, production, and purchasing, regarding incoming material quality.
Communicate with production staff and leadership to resolve quality-related questions and issues.
Collaborate with other quality teams to ensure quality standards are met throughout the entire production process.
Preferred Skills and Competencies:
Education and/or experience in engineering, technical, management or scientific discipline.
Prior experience working in a regulated industry such as Quality System Regulations 21CFR820 and/or ISO 13485.
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.
Experience creating and analyzing trend and pareto charts.
Experience or certification in process improvement and ISO process controls.
Excels at generating and maintaining organized and accurate records.
Experience with Microsoft software.
Prior supervisory / team leadership experience.
Other facts
About Insulet Corporation
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. Omnipod products are offered in 25 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.
What you'll do
- The Supervisor is responsible for leading the Incoming Quality Assurance team and managing inspection activities for materials entering the facility. They ensure compliance with quality standards and oversee the performance of the inspection team.
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