Senior Quality Engineer - Risk Management

Are you an experienced quality professional with a passion for risk management and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Senior Quality Engineer - Risk Management to join our Quality Assurance team.

Key Responsibilities

• Lead and coordinate all risk management activities, including Health Hazard Evaluations (HHEs), Field Safety Corrective Actions (FSCAs), and Field Safety Notices (FSNs).
• Ensure country-specific regulations and standards are incorporated into risk management activities.
• Provide input into complaints, change control, and CAPA processes, ensuring customer feedback is used for continuous improvement.
• Act as a primary source of regulatory knowledge within QA, supporting agile decision making and regulatory affairs input.
• Present status updates and KPIs to senior management, ensuring timely risk assessments and field actions.
• Collaborate across functions (Regulatory Affairs, Clinical, Quality Control, Operations, R&D, Engineering, Commercial) to ensure smooth completion of activities.
• Support post market surveillance and maintain global market access.
• Conduct internal audits and support external audits as a subject matter expert (e.g., FDA inspections, Notified Body audits).
• Provide training and guidance on risk management regulations and standards.

What We're Looking For

• Degree in Science/Engineering or equivalent background.
• In-depth knowledge of medical device regulations and standards (FDA, ISO, EU MDR).
• Experience with risk management and field management activities in a regulated environment.
• Strong analytical, problem solving, and communication skills.
• Certification such as CQE, CQA, or Lead Auditor (ISO 13485) is highly desirable.
• Experience with QMS tools and document control systems.
• Ability to work independently and influence change at all levels.
• Competence in IT technology (Microsoft Office and QA systems).