Insulet Corporation · 3 hours ago
Staff Auditor, Quality System Compliance & Audit (Hybrid - Acton, MA)
Acton, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$112K/yr - $169K/yr
8+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes. They are seeking a seasoned Staff Internal Quality Auditor to ensure the integrity and continuous improvement of their Quality Management System, leading multiple quality system processes and collaborating with cross-functional teams to enhance compliance and audit practices.
Health CareMedicalMedical Device
Responsibilities
Lead the planning, execution, and reporting of complex internal audits across global sites 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
Develop, maintain, and execute a robust, risk-based, internal audit program that proactively identifies compliance risks and drives continuous improvement
Serve as a key liaison and subject matter expert during external audits, including FDA inspections, Notified Body audits, and other regulatory authority engagements
Lead cross-functional teams supporting external audits including preparation, back-room management, issue tracking, and driving follow-up activities
Oversee audit responses including root cause analysis and ensure timely and effective implementation of CAPAs resulting from audit findings
Collaborate with global quality, regulatory, and other internal risk control teams to harmonize audit practices and ensure consistent compliance across the organization
Analyze audit data, identify trends, and present findings to management and/or regulatory bodies in support of the audit process, which may include coaching process owners and key stakeholders on compliance gaps, data, and/or resulting corrective actions
Design, develop, and facilitate training programs to enhance organizational understanding of quality system requirements, audit preparedness, and regulatory compliance
Influence key cross-functional stakeholders to adopt quality improvements and act as a catalyst for organizational change
Author and present high-impact presentations and executive summaries to senior management
Oversight and management of the internal guest auditor program
Mentor and train junior auditors and cross-functional teams on audit readiness, regulatory expectations, and quality system best practices
Partner with key stakeholders to support the development, implementation and continuous improvement of the established risk-based QMS and process-approach
Create and/or improve quality systems to ensure best practices are utilized including conducting assessments, write and execute quality plans, manage change
Regularly advise key stakeholders and management on ways to improve quality system effectiveness, with emphasis on preventive action
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 engineering, life sciences, or a related technical discipline; advanced degree preferred
8–10 years of experience in Quality Assurance or Regulatory Affairs in the medical device industry
Extensive functional knowledge of ISO 13485, 21 CFR 820, EU MDR 2017/745, MDSAP, and global regulatory requirements
Demonstrated success leading internal audits and managing external regulatory inspections
Strong command of audit, CAPA processes, risk management, and quality system controls with ability to educate others
Exceptional attention to detail with the ability to manage multiple high-priority projects in a fast-paced environment
Excellent written and verbal communication skills, including experience presenting to executive leadership
Proven ability to influence and lead cross-functional teams and drive change
High level of integrity, professionalism, and strategic/risk-based thinking
CQA, CMDA, or equivalent active certification
Ability to inspire and motivate cross-functional teams by building trust through active engagement, delivering impactful coaching and feedback, and fostering a culture of accountability and continuous improvement
Strategic mindset with a proactive approach to identifying and mitigating compliance risks
Strong analytical and problem-solving skills with a focus on root cause and sustainable solutions
Effective communicator with the ability to tailor messaging to diverse audiences, including executive leadership
Working with various digital business platforms and eQMS tools (LMS, LIMS, PLM, ERP, etc.)
Preferred
Expert user skills in the M365 Office suite including Teams, and SharePoint
Experience with electronic QMS solutions and audit management tools
Familiarity with additional international regulatory frameworks (e.g., Health Canada, TGA, PMDA)
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