Auditor

• Plan, conduct, and report internal audits in accordance with Insulet requirements, applicable international regulations and standards including ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and the MDSAP approach.
• Evaluate the effectiveness of the Quality Management System (QMS) and identify areas for improvement.
• Support external audits including FDA inspections, Notified Body audits, and other regulatory assessments with preparation, back-room support, and follow-up activities.
• As applicable, act as CAPA owner, approve CAPA plans, and help ensure CAPA effectiveness.
• Collaborate cross-functionally to ensure timely and effective CAPA.
• Maintain audit schedules, records, and documentation in compliance with regulatory and company requirements.
• Maintain audit process tools & resources including but not limited to Teams/SharePoint folder & file sharing organization & hierarchy, standard communication templates, and other related standard process tools.
• Act as a change agent to promote a culture of quality, continuous improvement, and compliance.
• Influence stakeholders across departments to drive quality initiatives and ensure audit readiness.
• Communicate clearly and effectively, both verbally and in writing, to all levels of the organization internally and externally.
• Demonstrated ability to communicate with clarity and confidence, including leading presentations and delivering effective training programs that drive understanding and engagement.
• Partner with key stakeholders in the planning and execution of the internal audit process for all Insulet locations.
• Identify and assist in the resolution of quality-related issues, especially those that impact the quality system processes.
• Provide input and support in the design, development, and delivery of training programs to enhance organizational understanding of quality system requirements, audit preparedness, and regulatory compliance.
• Support implementation of computer-based quality system platforms including creation of associated work instructions and facilitation of training.
• Provide coaching, advice, and oversight of auditors in-training in support of the guest auditor program.
• Review procedures to ensure compliance with applicable regulatory and corporate standards.
• Perform additional duties as part of the Quality Systems team as required.

Senior Auditor, Quality System Compliance – Audit

Claims Auditor I, II, Senior

Senior Compliance Claims Auditor, Data

Senior Compliance Claims Auditor

Field Auditor