Staff Auditor, Quality System Compliance – Audit

Job Description:

• 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

Requirements:

• 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.)

Benefits:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

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