Integra LifeSciences

Senior QE Engineer

Vacancy ID
2017-25420
Location
CH-NE-Le Locle
Position Type
Regular Full-Time
Category
Quality Assurance

Overview

This position serves as a Senior QE Engineer for the Le Locle, Switzerland facility, responsible for being the quality representative of different production lines (for example molding department, valves manufacturing) and for being in charge of projects such as validation of line extension of hydrocephalus valves, new equipment validations (mold, sterilizer, cleaning equipment, gluing process).

 

***It is a fixed-term contract for 1 year (maternity leave replacement).***

Responsibilities

  • Quality support for production and for various projects
  • Plan, coordinate and direct the quality aspects of process validation
  • Write validation documentation (protocols, reports, process specifications, work instructions, pFMEA, master validation plan)
  • Provide projects updates and presentations
  • Review and approve changes to documentation and processes
  • Apply and enforce GMP
  • Non-conformance management (initiation / evaluation / disposition on the batches / investigation)
  • Quality control technical support
  • Participation in development and updating of procedures and other quality documents
  • Participation in validations of new processes (Processes, products, methods & software)
  • Validation of different integrated processes of Integra LifeSciences & Codman Neurosurgery

Qualifications

  • Minimum of 2 years’ experience in Quality Engineering area (Medical device or pharma industry experience highly preferable)
  • Engineering degree or equivalent
  • Knowledge in statistic ( capability, gage RR, Anova test, control chart)
  • Quality knowledge in the medical industry
  • Organized and methodical
  • Outstanding communication skills with outgoing and proactive attitude
  • Solid organizational skills
  • Team spirit
  • Fluent in French and English
  • Ability to work with cross functional team (R&D, RA, manufacturing engineering, planning, production)
  • Proactive, rigorous, autonomous

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