Director, Global Quality Risk Management

Working Location: NATIONWIDE 

Workplace Flexibility: Remote

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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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.

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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 role is responsible for leading the development, implementation, and continuous improvement of the Olympus risk management strategy and processes across the medical device lifecycle. This role ensures compliance with global regulatory requirements (e.g., ISO 14971, FDA 21 CFR Part 820, EU MDR) and drives a robust risk culture across R&D, Quality, Manufacturing, Medical Safety, Medical Affairs and Post Market functions.

 

This position oversees risk governance processes, mentor and train cross-functional teams and functional leaders and ensure that robust systems are in place to ensure product risks are identified, assessed, and controlled to protect patient safety, product efficacy, and business continuity.

Job Duties

• Serve as the Global Process Owner (GPO) for Olympus.
• Develop and own the enterprise risk management framework for medical device products across the full lifecycle.
• Serve as the Olympus primary subject matter expert on risk management processes, standards, and regulatory expectations.
• Partner with R&D, Quality, Manufacturing, Regulatory, Clinical/Medical Affairs, Medical Safety and Post Market teams to ensure risk considerations are proactively integrated into all phases of product development and commercialization.
• Lead risk governance forums, management reviews, and escalation processes for product and process risks.
• Maintain and continuously improve the Olympus risk management systems in accordance with ISO 14971, ISO 13485, IEC 62366, and applicable FDA/EU requirements.
• Oversee processes for creation, review, and approval of risk management files (RMFs) including hazard analyses, FMEAs, fault tree analyses, benefit risk assessments, and risk control verification.
• Through development, deployment and maintenance of global processes, ensure traceability between design inputs, hazards, risk controls, verification/validation, and post market surveillance.
• Monitor evolving regulatory trends and standards related to risk management; communicate changes and update processes as needed.
• Develop and implement a comprehensive global training syllabus in risk management for all functions.
• Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP).
• Other Quality Assurance responsibilities as assigned by Management.

Job Requirements

Required:

• Bachelor’s, and/or Master’s degree in an engineering, scientific or technical discipline required.
• Minimum of 12 years of professional experience or equivalent training/education in Quality, Design Assurance or Risk Management in healthcare industry (medical device, biotechnology or pharma).
• Minimum of 8 years working specifically in the medical device industry.
• Minimum of 5 years in a significant leadership role (team or supervisory).
• Expert-level knowledge of ISO 14971, FDA QMSR, ISO 13485, EU MDR, and relevant product standards.
• Success leading at least one company- or site-wide transformation/training/deployment effort as process owner for risk management.
• Demonstrated track record of writing and implementing effective and robust Risk Management procedures with company-wide purview.
• Demonstrated leadership of cross functional teams within regulated industries.
• Deep analytical skills and experience in FMEA, hazard analysis, FTA, and benefit risk evaluation, and the proven ability to teach these tools to others across an organization.
• Proven ability to interact with regulatory bodies and lead audit interactions.
• Familiarity with human factors engineering (IEC 62366) and cybersecurity risk processes.
• Strategic thinking and systems mindset.
• Strong colla