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Employers

Manager Verification and Validation - Autonomous role, St. Gallen

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Location:

St. Gallen, Switzerland 

Job Category:

Healthcare

Salary:

CHF€110,000.00 - CHF €130,000.00
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Job Reference:

EM/200574/03_1540565912

Job Views:

26

Posted:

26.10.2018

Expiry Date:

10.12.2018
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Job Description:

The company has an international environment and is recognized as the market leader in their field. With constant growth on their side, they offer you the opportunity to join their ranks as a manager that will take control of the processes and come up with new ways of improving them. The success you aim for will therefore be entirely in your hands.

Some information on the responsibilities and requirments:

Key Responsibilities:
• • 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

Key Requirements:
• • 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
• • 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
Company Info
NonStop Recruitment
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site:
Save Contact
Company Profile


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