Software QA Engineer / Ingenieur (m/f) - Medical Devices Software QA Engineer / Ingenieur (m/f) - Medical  …

Badenoch + Clark (Switzerland)
in Zürich
Festanstellung, Vollzeit
Seien Sie der erste Bewerber
Competitive
Badenoch + Clark (Switzerland)
in Zürich
Festanstellung, Vollzeit
Seien Sie der erste Bewerber
Competitive
Software QA Engineer / Ingenieur (m/f) - Medical Devices
Our client is an innovative company and leader in its field.
Responsibilities :
  • Manage all quality assurance activities related to software development, verification, validation,
  • and overall system functionality according to IEC 62304 standard;
  • Lead software standard operating procedures, software test methodologies and software verification & validation protocols;
  • Perform computer software validation used for the monitoring and measurement of requirements accordingly to Quality Management System (AAMI TIR 36);
  • Support engineers on regulatory compliance for Software, Cybersecurity, Artificial Intelligence and General Data Protection Regulation;
  • Responsible of effective design change control activities during the product life cycle;
  • Conduct and support key supplier's audits;
  • Contribute to the set up and improvement of the Quality Management System (ISO 13485/21 CFR820): internal audits, CAPAs, process deployment.


Profile :
  • MS in Engineering or relevant Life Science discipline;
  • At least 5 years of experience in a similar position in the medical device industry (preferably with class III medical devices);
  • Very good understanding of the EU, Swiss and USA medical device regulations, including the MDR
  • 2017/745/EU, the FDA 21 CFR Part 820 and ISO 13485 requirements;
  • Good experience with FDA software validation, Cybersecurity and Artificial Intelligence guidance's and IEC62304 Software Lifecycle process standard requirements;
  • Very high attention to detail;
  • Fluent in English; proficiency in French a plus.


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