Design Quality Assurance Specialist

Salary/Rate:60,000EUR - 80,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs, Quality, R&D
Job ref:24832
Post Date:05. 01. 2024

About the Role

Design Quality Assurance Specialist

Location:  Frankfurt area (high degree of remote flexibility)

Our client is a global leader in the treatment of renal disease and is currently looking for a Design Quality Assurance Specialist to support the ensure the quality of design control activities.

You would be responsible for the support of project design and development to carry out product development processes correctly and comply with all relevant standards.

Your tasks:
  • Ensure that all design control deliverables adhere to applicable regulatory requirements and design controls SOPs.
  • Creation and monitoring of compliance metrics of design controls in development and design change activities.
  • Providing Management / Quality Review input for design & development.
  • Review and approve all product development and change management initiatives to ensure they comply with their Quality Management System / SOP standards.

Your profile:
  • A degree in a technical or scientific field.
  • Several years of experience in research and development, regulatory affairs, or quality management.
  • Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.)
  • High degree of knowledge in CAPA, quality management, and risk management standards (ISO 13485 and ISO 14971).
  • Independent working structure.
  • Fluent in written and spoken English and advantage of German skills.

  • Very international environment.
  • High home office flexibility and flexible working hours.
  • Continuous support in the development.
  • Pension scheme.

 Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology.