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Standard Compliance Quality Specialist
Descrizione del lavoro
A medical device company in Scotland is seeking a Standards Compliance Quality Specialist to enhance quality assurance and regulatory compliance efforts. Responsibilities include monitoring regulations, maintaining compliance throughout the product lifecycle, and providing training on standards. Candidates with a degree in Science/Engineering and knowledge of medical device regulations are encouraged to apply. This position requires strong analytical and problem-solving skills, alongside effective communication in cross-functional teams.
Competenze
- Degree in Science/Engineering or equivalent background.
- Class III medical device knowledge is desirable.
- In-depth knowledge of medical device regulations and standards.
Mansioni
- Monitor and evaluate new and revised standards and regulations.
- Review updates to ensure ongoing compliance.
- Maintain compliance throughout the product lifecycle.
- Identify gaps in regulations/standards and coordinate actions.
Conoscenze
Formazione
Strumenti
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.
- 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.
- 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.
- 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).
* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.