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Process Verification

vor 3 Monaten


Rostock, Mecklenburg-Vorpommern, Deutschland BIOTRONIK Vollzeit
(Senior) Process Verification & Validation Engineer (m/w/d)

CORTRONIK GmbH is a proud member of the BIOTRONIK Group, a renowned company specializing in the creation of cutting-edge cardio- and endovascular implants and catheters for various medical purposes. Headquartered in vibrant Berlin, Germany, we are dedicated to developing, manufacturing, and delivering top-notch medical products that incorporate the latest technological advancements and research findings. Our continued success is a direct result of the expertise and collaborative efforts of our exceptional team.

Your Responsibilities
  • Lead and oversee process V&V activities in development projects as a sub-project manager
  • Coordinate mechanical and analytical test procedures for validations, ensuring accurate data evaluation and documentation
  • Drive continuous enhancement of processes and workflows before project handover to production
  • Provide support during production transfer phases
  • Guarantee adherence to quality standards and regulatory specifications in process V&V during development
  • Contribute to the improvement of business processes
  • Assist technical departments in interactions with regulators and audits
Your Profile
  • Hold a degree or equivalent qualification with relevant practical experience
  • Have a minimum of 3 years of hands-on experience in a similar role
  • Demonstrate proficiency in international regulatory frameworks related to process verification & validation, including test method validations such as MDR, ISO 13485, 21 CFR 820, cGxP
  • Utilize verification/validation tools and methodologies effectively
  • Experience in defining, organizing, and managing department-specific work packages
  • Possess excellent written and verbal communication skills in both German and English
  • Knowledge of medical device products, vascular intervention, and combination products is a plus