Validation Engineer II

vor 24 Stunden

Le Locle, Schweiz Integra Lifesciences Switzerland SAS Vollzeit

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.

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 analysis 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 practice.
  • Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
  • Use of Agile, Oracle, Minitab is a plus.
  • Proficient in Microsoft Office tools.
  • Strong knowledge of statistical techniques.

Girardet 29, 2400 Le Locle

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