Senior Quality Engineer

6 days ago

Renfrew, United Kingdom Terumo Aortic Full time

Senior Quality Engineer - Risk Management Join to apply for the Senior Quality Engineer - Risk Management role at Terumo Aortic 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). Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Terumo Aortic by 2x Get notified about new Senior Quality Engineer jobs in Renfrew, Scotland, United Kingdom. #J-18808-Ljbffr

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