Insulet Corporation · 2 months ago
Senior Auditor, Quality System Compliance & Audit (Hybrid - Acton, MA)
US - Massachusetts (Acton - Office)
Full-time
Hybrid
Mid, Senior Level
$90K/yr - $135K/yr
5+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. The Senior Auditor will support and manage multiple quality system processes, including internal/external audits and corrective actions, ensuring compliance with international regulations and standards.
Health CareMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree in a scientific, engineering, or related discipline
5–7 years of experience in Quality Assurance or Regulatory Affairs in the medical device industry; equivalent combination of education and relevant experience may be considered
In-depth working knowledge in the application of ISO 13485, 21 CFR 820, EU MDR 2017/745, and MDSAP
Proven experience supporting and responding to FDA and Notified Body audits
Strong understanding of CAPA processes and root cause analysis methodologies
Strong attention to detail and ability to manage multiple high-priority projects simultaneously
Excellent written and verbal communication skills
Demonstrated ability to influence others and lead change initiatives
High level of integrity, professionalism, and strategic/risk-based thinking
ISO 13485 Qualified lead auditor
Effective written and verbal communication skills
Proactive approach to continuous improvement with a solution-based mindset
Interpersonal skills to promote and accomplish constructive solutions to problems
High level of attention to detail and accuracy in all aspects of daily activities
Team-oriented with the ability to build trust and work collaboratively across departments
Analytical thinking and problem-solving skills to support issue identification, root cause analysis and CAPA development
Commitment to continuous learning and professional development in quality and regulatory standards
Working with various digital business platforms and eQMS tools (LMS, LIMS, PLM, ERP, etc.)
Preferred
Certified Quality Auditor (CQA) or equivalent certification
Relevant 13485 training/certification from an organization recognized in industry
Advanced user skills in the M365 Office suite including Teams, and SharePoint
Experience with electronic QMS platforms
Familiarity with global regulatory requirements beyond the U.S. and EU
Experience with PLM tools such as Agile and/or Arena
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase