Manager Verification and Validation Lab

Manager Verification and Validation Lab

Leica Microsystems

Heerbrugg, Switzerland

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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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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