Leads all company activities related to Verification and Validation of new products, as well
as related instrumentation and their handling.
Defines, supervises and executes V V masterplan for products and bench tests, in order to
ensure product compliance with applicable regulatory standards.
Professional responsibility over BioAnalytics in the company.
Duties and Responsibilities
Prepares V V protocols and reports throughout product lifecycle (URS, PRS, Design
Reviews, final product design validation tests).
Manages V V team, including engineers, technicians and students, as well as their
professional training and supervision.
Has overall responsibility for companys Risk Management process.
Defines and writes testing work instructions.
Supports engineering, manufacturing and QC activities, participates in ECO and MRB
processes.
Defines requirements for testing
Requirements: Education - B.Sc. equivalent or higher, Biomedical Engineering.
At least 5 years of experience in V V of medical devices.
Very high interpersonal skills.
Excellent technical writing skills (English
Advantages
Experience in orthopedic products
Experience in a QMS environment
Familiarity with ISO 13485
Managerial experience
This position is open to all candidates.