Quality Assurance Specialist

vor 1 Tag


Le Locle, Neuenburg, Schweiz Randstad Vollzeit

At Randstad, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our medical devices.

Job Summary

We are looking for a talented professional with experience in validation and quality assurance to join our team. As a Quality Assurance Specialist, you will be responsible for generating and executing qualification/validation protocols, working with project teams to develop validation strategies, and completing test method validation, gauges R&R studies, and other qualifications or studies to support product testing.

Key Responsibilities:
  • Generate and execute qualification/validation protocols
  • Develop statistically based sampling plans for in-process and final test sequencing
  • Ensure all projects are in compliance with cGMP, cGLP, QSR, and ISO requirements
  • Support and address comments and suggestions associated with validation and engineering documentation
  • Protocol, deviation, and summary report generation and approval

As a Quality Assurance Specialist, you will also have excellent organizational and communication skills, experience with qualifying medical devices, manufacturing equipment, or external components, and knowledge of statistical techniques.

Requirements:
  • Bachelor's degree in Engineering or Science
  • 2-5 years of experience in a validation or quality assurance role for a medical device or pharmaceutical environment
  • Fluency in English and good command of French
  • Excellent technical writing skills and understanding of good documentation practice
  • Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements


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