Manager Verification and Validation Lab
  Leica Microsystems
Heerbrugg
vor 1 Tg.

Description

  • Definition of the strategy and planning of all V&V activities
  • Responsible for the definition and improvement of test processes, techniques, tools and laboratory management
  • Improvement and extension of automated duration testing
  • Definition, improvement and implementation of SOPs
  • Verification and validation planning, execution and reporting according the applicable standards, directives and regulations for medical devices
  • Participation in review meetings of requirements, specification, design and finally verification and validation reports
  • Coach, motivate and engage with direct reports to drive Verification and Validation to the next level by having a motivated and high performing, winning team
  • Planning of the team resources across all projects according schedules and all other lab topics.
  • Responsible for the test area, equipment park and test infrastructure
  • Responsible for the on-time delivery of the R&D part for the Device History File (main lead is with RA / QA) plus user documentation (IFU)
  • Support with production issues and customer complaints plus proposals for product improvement and cost savings
  • Support of the production during design transfer in NPI projects including the Outgoing Inspection planning and reporting
  • Qualifications

  • Bachelor or Master in Mechanical or Medical Engineering
  • Minimum 7 years of experience in the area of Verification, Requirement Management and Traceability, out of that in minimum 5 years in the field of Medical Devices.
  • Minimum 5 years of technical experience in team management and / or management of complex projects
  • Experience in Risk management for Medical Devices
  • Familiar with regulated (medical) environment (FDA / GMP, QSR, IVDD, ISO 13485), and Laboratory- and Test automation
  • Experience in Quality Engineering is appreciated
  • Further education in QSR requirements and Project Management is appreciated
  • Strong written and verbal German and English communication skills
  • Ability to create a V&V Strategy for Medical by understanding risks, strengths, weaknesses, opportunities and threats and translates this into actionable plans
  • Proven leadership skills with the ability to take the lead in a team, manage by influence and also function as a team player
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