Position Overview:
The Quality System Specialist is responsible for performing duties associated with maintaining effective quality systems and compliance at Insulet Corporation. Responsibilities: include the administration of key quality systems as well as the measurement and reporting of Quality System performance. The position is engaged in improvement projects, ensuring efficient and compliant quality systems, and interfaces with all aspects of the business.
Responsibilities:
Minimum Requirements:
Preferred Skills and Competencies:
Physical Requirements:
The Quality System Specialist is responsible for performing duties associated with maintaining effective quality systems and compliance at Insulet Corporation. Responsibilities: include the administration of key quality systems as well as the measurement and reporting of Quality System performance. The position is engaged in improvement projects, ensuring efficient and compliant quality systems, and interfaces with all aspects of the business.
Responsibilities:
- Maintain Quality System processes as system administrator, manage workflows, and perform related tasks (e.g. CAPA effectiveness checks).
- Work collaboratively with other functional groups to ensure timely completion and documentation of actions taken related to meeting Quality System requirements.
- Perform Quality System monitoring and analysis activities and publish management reports.
- Lead or participate as the QA representative in Quality System improvement projects.
- Participate in computer based Quality Management System design and implementation.
- Perform Internal Audits, and support 3rd Party audit activities.
- Maintain quality records, and logs (e.g. NCMR, CAPA, and Internal/External Audit Records, critical Meeting Presentations, Rosters and Minutes, etc.), in compliance with FDA QSR and ISO 13485 standards.
- Performs other duties as required.
Minimum Requirements:
- AS degree, in a business/computer systems/project management or quality management curriculum and/or equivalent combination of education and experience. Bachelor’s degree preferred.
- Advanced knowledge of Microsoft Office programs (e.g. Word, Excel, Access, and PowerPoint).
- Experience leading improvement projects.
Preferred Skills and Competencies:
- BA/BS Degree
- 1-2 years’ work experience in a regulated industry, preferably medical devices.
- Knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and/or ISO 13485 quality system standards with experience in Certification inspections.
- Effective verbal and written communication skills.
- Ability to communicate at multiple levels of an organization.
- Ability to generate and maintain organized and accurate records.
- Ability to organize tasks and judge priorities.
Physical Requirements:
- None
NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $72,000.00 - $108,000.00. 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!
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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