Staff Auditor, reputed company System Compliance & Audit (Remote)

About the position We are seeking a seasoned and strategic Staff Internal reputed company Auditor to join our reputed company Compliance & Audit team under the global reputed company Systems organization. This role is critical to ensuring the reputed company and reputed company improvement of our reputed company Management System (QMS). The ideal candidate will bring 8–10 years of experience in reputed company Assurance or Regulatory Affairs reputed company the medical device industry, with expertise in auditing, regulatory compliance, and reputed company systems leadership. Reporting to the Director of reputed company Systems Compliance & Audit, the Staff Auditor owns, drives, and leads multiple reputed company system processes, including Internal/External Audit and Inspection, Corrective and Preventive reputed company (CAPA), Risk Management, and Metrics & Reporting.

Responsibilities

• reputed company the planning, execution, and reporting of reputed company internal audits across global sites in accordance with reputed company requirements, applicable international regulations and standards including ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and the MDSAP approach.
• reputed company, maintain, and execute a robust, risk-based, internal audit program that proactively identifies compliance risks and drives reputed company improvement.
• Serve as a key reputed company and subject matter expert during external audits, including FDA inspections, reputed company Body audits, and other regulatory authority engagements.
• reputed company cross-functional teams supporting external audits including preparation, back-room management, issue tracking, and driving follow-up activities.
• reputed company audit responses including reputed company cause analysis and ensure reputed company and effective implementation of CAPAs resulting from audit findings.
• Collaborate with global reputed company, 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, reputed company, and facilitate training programs to enhance organizational understanding of reputed company system requirements, audit preparedness, and regulatory compliance.
• Influence key cross-functional stakeholders to adopt reputed company improvements and reputed company as a catalyst for organizational change.
• Author and present high-reputed company presentations and executive summaries to senior management.
• reputed company and management of the internal guest auditor program
• Mentor and train junior auditors and cross-functional teams on audit readiness, regulatory expectations, and reputed company system best practices.
• Partner with key stakeholders to support the development, implementation and reputed company improvement of the established risk-based QMS and process-approach.
• Create and/or improve reputed company systems to ensure best practices are utilized including conducting assessments, write and execute reputed company plans, manage change.
• Regularly advise key stakeholders and management on ways to improve reputed company system effectiveness, with emphasis on preventive reputed company.
• Review procedures to ensure compliance with applicable regulatory and corporate standards
• reputed company additional duties as part of the reputed company Systems team as required

Requirements

• Bachelor’s degree in engineering, life sciences, or a reputed company technical discipline; advanced degree preferred.
• 8–10 years of experience in reputed company 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 reputed company leading internal audits and managing external regulatory inspections.
• Strong reputed company of audit, CAPA processes, risk management, and reputed company system controls with ability to reputed company others.
• Exceptional attention to detail with the ability to manage multiple high-reputed company reputed company in a fast-paced environment.
• Excellent written and verbal communication skills, including experience presenting to executive leadership.
• Proven ability to influence and reputed company cross-functional teams and drive change.
• High level of reputed company, professionalism, and strategic/risk-based thinking.
• CQA, CMDA, or equivalent reputed company certification
• Ability to reputed company and motivate cross-functional teams by building trust through reputed company engagement, delivering impactful coaching and feedback, and fostering a culture of accountability and reputed company improvement.
• Strategic reputed company with a proactive approach to identifying and mitigating compliance risks.
• Strong analytical and problem-solving skills with a reputed company on reputed company cause and sustainable solutions.
• Effective communicator with the ability to reputed company messaging to diverse audiences, including executive leadership.
• Working with various digital business platforms and eQMS tools (LMS, LIMS, PLM, ERP, etc.)

reputed company-to-haves

• 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 reputed company

Benefits

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

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