Standard Compliance Quality Specialist
1 week ago
Title: Standard Compliance Quality Specialist at Terumo Aortic Location: Renfrew, Scotland, United Kingdom Are you passionate about quality assurance and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Standards Compliance Quality Specialist to join our External Quality team. Key Responsibilities Monitor and evaluate new and revised standards/regulations for impact on products and QMS processes. Review updates to regulations and standards to ensure ongoing compliance of products and systems. Maintain compliance throughout the product lifecycle—from design and development to manufacturing and post‑market surveillance. Identify gaps in regulations/standards and coordinate actions with relevant departments. Facilitate closure of compliance actions and monitor status via trending. Present status updates during meetings and highlight risks to management. Ensure all processes and procedures meet regulatory standards (EU MDR, ISO 13485, 21 CFR Part 820/QMSR, Japan MHLW Ordinance 169, and other country‑specific regulations). Collaborate with R&D, manufacturing, and regulatory teams to integrate compliance into product design and development. Provide training and guidance on regulations/standards and compliance best practices. Conduct internal audits and support external audits as a subject matter expert (e.g., FDA inspections, Notified Body audits, Customer audits). Generate and maintain trending data for the Standards Management process and publish as part of QMS governance forums. Update QMS documentation with respect to key changes for standards, working closely with cross‑functional SMEs. What We’re Looking For Degree in Science/Engineering or equivalent background. Class III medical device knowledge (desirable). In‑depth knowledge of medical device regulations and standards (FDA, ISO, EU MDR). Experience with QMS tools and document control systems. Strong analytical, problem‑solving, and communication skills. Certification such as CQE, CQA, or Lead Auditor (ISO 13485) is highly desirable. Ability to work independently and influence change with objective information and well‑structured communications. Competence in IT technology (Microsoft Office and QA systems). Seniority level Entry level Employment type Full‑time Job function Finance and Sales Industries Medical Equipment Manufacturing #J-18808-Ljbffr
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Renfrew, United Kingdom Terumo Aortic Full timeA leading medical device manufacturer based in Renfrew, Scotland, is looking for an entry-level Standards Compliance Quality Specialist to ensure regulatory compliance of products. The role includes monitoring standards, conducting audits, collaborating with teams, and providing guidance on best practices. Candidates should have a science or engineering...
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