Insulet Corporation
Supervisor, Quality Operations (12 Hour Weekend Night Shift - Onsite)
US - Massachusetts, USA
Sponsorship not specified$74k-$111kDetected 7 hours ago
Process ImprovementFDA RegulatoryMedical DevicesLeadershipCommunicationWritingLean Manufacturing
About the role
- This is an excellent opportunity for an experienced Quality professional who enjoys leading teams in a highly regulated manufacturing environment.
- Candidates with experience in medical devices, ISO 13485, FDA regulations, Lean Six Sigma, and quality systems will thrive in this dynamic, on-site position where they can make a direct impact on product quality, compliance, and operational excellence.
- Working hours are 6:00 pm - 6:30 am, Friday - Sunday.
Responsibilities
- Hires, manages, and mentors direct reports including daily interactions and performance reviews.
- Provides leadership to team members, including but not limited to, training support on processes and
- Performs complex tasks to ensure compliance with quality standards.
- Collaborates with Quality Engineers with equipment troubleshooting and failure analysis.
- Manages, facilitates, and participates in continuous improvement projects.
- Performs other duties as assigned.
- 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.
Requirements
- Bachelor's degree or equivalent experience
- Combined 5 years of Quality Technician and/or supervisory experience
- Ability to operate inspection hand tools and instrumentation
- Ability to handle team interpersonal conflicts and find an acceptable resolution.
Nice to have
- Preferred Skills and Competencies:
Skills
- Education and/or experience in an engineering, technical or scientific discipline.
- Prior experience working in a regulated industry such as Quality System Regulations 21CFR820 and/or ISO 13485.
- 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 Lean Six Sigma, SPC, ASQ, and/or ISO process controls.
- Excels at generating and maintaining organized and accurate records.
- Experience with Microsoft software.
Compensation
- Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $73,800.00 - $110,700.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:
Company info
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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