Insulet Corporation

Job Title: Co-op, Design Quality Assurance Engineering. They will interface with other Insulet departments (e.g., varying levels of Management, Systems Engineering, Software Engineering, Design Verification and Regulatory Affairs) as well as other functional teams on initiatives related to product development and lifecycle/sustaining project support.. Support the team with activities to support all regulatory submissions [i.e., 510 (k), PMA, etc.. Previous Co-op experience in Quality Assurance within an FDA, ISO or other regulated environment preferred. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.

quality assurance

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! Job Title: Co-op, Design Quality Assurance Engineering Department: QA Design FLSA Status: Non-Exempt Position Overview: The Design Quality Assurance Engineering Co-op will work closely with the team, expanding on their knowledge of FDA 21 CFR 820, ISO 13485 compliance for Medical Device Quality Management System (QMS) best practices, including design controls, product and process verification/validation as well as risk management. This position requires strong interpersonal skills to effectively communicate design and development regulations, implement, manage, and improve the company's Quality Management System and support design and development activities and teams. This position is responsible for supporting both commercialized and new products and/or markets. They will interface with other Insulet departments (e.g., varying levels of Management, Systems Engineering, Software Engineering, Design Verification and Regulatory Affairs) as well as other functional teams on initiatives related to product development and lifecycle/sustaining project support. Ensuring that ambiguities and conflicting requirements are resolved are critical to the success of the position. Responsibilities: <ul><li>Support the team with activities to support all regulatory submissions [i.e., 510 (k), PMA, etc.]</li><li>Support Verification and Validation activities, including assisting in the development and review of V&V requirements, protocols and reports as well as other relevant DHF documentation</li><li>Collaborate with Management to optimize Design Control processes</li><li>Collaborate with the team to review and approve Design Control documents and DHF deliverables</li><li>Support compliance to Design Controls and works towards becoming an expert to the organization</li><li>Support Risk Management activities and compliance to standards and regulation</li><li>Perform other duties as required</li></ul> Education and Experience: Minimum Requirements: <ul><li>Currently enrolled in a BS degree in Engineering (i.e., Biomedical, Computer, Electrical, Mechanical)</li><li>Experience collaborating and communicating with individuals at multiple levels in an organization</li><li>Ability to follow up with task owners and varying functional groups to close out open items</li><li>Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint)</li><li>Strong verbal and written communication skills</li><li>Requires limited supervision</li><li>Ability to organize and judge priorities</li><li>Ability to generate and maintain accurate records</li></ul> Preferred Skills and Competencies: <ul><li>Previous Co-op experience in Quality Assurance within an FDA, ISO or other regulated environment preferred</li><li>Skilled in computer use including word processing, spreadsheet, and database applications required</li></ul><ul><li>Able to work effectively in a fast paced, high-stress and high-energy environment required</li></ul> Physical Requirements: Typical office setting NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote Additional Information: The US base salary range for this full-time position is $23.00 - $29.75. 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. 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. (Know Your Rights)

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