Validation Engineer II

vor 23 Stunden

Le Locle, Schweiz Integra Lifesciences Switzerland SAS Vollzeit

Responsibilities

  • Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
  • Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
  • Facilitate the execution of Process FMEA and other applicable risk analyses as deemed appropriate.
  • Complete test method validation, gauges R&R studies, and other qualifications or studies to support product testing.
  • Scheduling coordination, material allocation, and alignment of personnel in order to successfully complete validation assignments.
  • Develop statistically based sampling plans for in-process and final test sequencing.
  • Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable requirements.
  • Support and address comments and suggestions associated with validation and engineering documentation.
  • Protocol, Deviation, and summary report generation and approval.
  • Change control, non-conformance, and CAPA support.
  • Participate in FDA inspections, ISO certifications, surveillance audits, and customer audits.

Qualifications:

  • Bachelor's Degree in Engineering (Medical Device, Biomedical, Mechanical or Chemical) or Science (Biology, Chemistry).
  • 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical company.
  • Fluent in French and English.
  • Demonstrates excellent organizational and communication skills.
  • Experience with qualifying medical device manufacturing equipment.
  • Excellent technical writing skills with a thorough understanding of good documentation practices.
  • Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
  • Experience with Agile, Oracle, and Minitab is a plus.
  • Proficient in Microsoft Office tools.
  • Strong knowledge of statistical techniques.
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