Director, Global Quality Risk Management

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 collaboration skills and the ability to work across functions in a team environment.
• Able to build consensus and drive decision-making in a solution-oriented manner that promotes patient-focused product quality and adherence to applicable standards and regulations. Willingness to be accountable  for important decisions with minimal supervision.
• Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.
• Ability to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines. Provides solutions to highly complex, and significant  issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths.
• Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards.
• Proactively identifies and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
• May mentor, manage, and develop direct reports.
• Excellent written and oral communication and organizational, project management skills.
• Demonstrated track record influencing without authority across functions.
• Expert judgment in risk assessment and decision making.
• Ability to operate in a fast paced, regulated environment.
• Excellence in documentation, governance, and compliance.
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
• Travel: 10-40% depending on assignment and regional/global responsibilities.
• Hours: Willing to embrace flexibility in work hours (occasional evenings or early mornings) to accommodate direct reports, dotted line reports, stakeholders and team collaborators located in other regions.

Preferred:

• Experience with complex systems (e.g., software driven devices, combination products, robotics, diagnostics, etc) is preferred.
• Certification(s) in quality or risk disciplines (e.g., CQE, CSQE, CQA, RAC, ISO 14971 lead assessor) is a plus.
• Participation in a standards developing organization or committee in the development of risk management or other quality standards is a plus.