Quality Engineer

Integra Lifesciences Switzerland SAS
Spitalstrasse Haus 33, 2400 Le Locle
3T
  • 06.12.2023
  • 100%
  • Fachverantwortung
  • Festanstellung

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Quality Engineer

Responsibilities

  • Quality support for production (various production lines) and for various projects
  • Plan, coordinate and direct the quality aspects of process validation
  • Non-conformance management (initiation / evaluation / disposition on the batches / investigation)
  • CAPA management
  • Review and approve changes to documentation and processes
  • Work validation documentation in collaboratin with engineering (protocols, reports, process specifications, work instructions, pFMEA, master validation plan)
  • Provide projects updates and presentations
  • 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
  • Apply and enforce GMP

Qualification

  • 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
Girardet 29 2400 Le Locle