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).
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