**Working Location: Massachusetts, Westborough; Nationwide** **Workplace Flexibility: Remote** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ​_** **_​_** ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: **Patient Focus, Integrity, Innovation, Impact and Empathy.** Learn more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** This is a global leadership role responsible for developing, leading, and continuously improving the company's corporate and internal audit programs across all manufacturing, distribution, R&D, and support sites worldwide. This role ensures ongoing compliance with applicable global regulatory requirements, internal Quality Management System (QMS) standards, and industry best practices within the medical device industry. This role will lead global transformational change for Olympus Corporate Compliance. This position leads a team of corporate audit professionals responsible for assessing site readiness, identifying compliance risks, driving sustainable corrective and preventive actions (CAPAs), and promoting a culture of quality and continuous improvement. The role serves as a strategic partner to Quality, Regulatory Affairs, Operations, and executive leadership to ensure inspection readiness and compliance excellence across the enterprise. **Job Duties** + Lead and oversee the global corporate audit program across all company sites and critical business functions. + Own, development, deployment and continuous improvement of the corporate and internal audit quality system process. + Establish and maintain risk-based corporate and internal audit strategies aligned with applicable global regulations and standards, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, and other regional requirements. + Direct planning, execution, reporting, and follow-up activities for corporate and internal quality audits. + Evaluate site compliance to internal QMS requirements, regulatory expectations, corporate procedures, and industry standards. + Drive enterprise-wide compliance transformation and inspection readiness and ensures sustained compliance across manufacturing, design, clinical, distribution, and post-market activities. + Partner with site leadership and functional stakeholders to address identified gaps, implement effective CAPAs, and strengthen quality system maturity. + Monitor and analyse inspection trends, systemic issues, and quality metrics to proactively identify compliance risks and opportunities for improvement. + Provide strategic guidance and subject matter expertise during regulatory agency inspections and external audits. + Develop standardized audit methodologies, tools, training programs, and governance processes to ensure consistency and effectiveness globally. + Build and lead a high-performing global team of internal inspectors and audit professionals, fostering a culture of accountability, collaboration, and continuous improvement. + Prepare and present corporate audit outcomes, compliance trends, and risk assessments to executive leadership and quality governance forums. Makes recommendations for changes. + Maintain awareness of evolving global regulatory requirements and industry expectations to ensure ongoing program effectiveness. **Job Qualifications** **Required:** + Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field required; advanced degree preferred. + Minimum of 12 years of progressive experience required in Quality Assurance, Regulatory Compliance, or Quality Systems within the medical device or regulated healthcare industry. + Significant experience required leading global quality audit or internal inspection programs in a multinational organization. + Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP, and other international regulatory frameworks. + Demonstrated experience interacting with regulatory agencies and supporting external inspections. + Proven leadership experience managing global teams and influencing senior stakeholders across complex organizations. + Certified Lead Auditor or equivalent quality certification (ASQ CQA, CQE, or similar). + Experience supporting remediation programs, compliance transformations, or quality system harmonization initiatives. + Strong analytical, communication, organizational, and problem-solving skills. + Familiarity with digital quality systems, audit analytics, and risk management methodologies. + Ability to travel domestic and internationally as required based on business needs. **Why join Olympus?** We offer a holistic employee experience supporting personal and professional well-being thr