Quality System Specialist

vor 2 Wochen

Eysins, Schweiz AliveDx Vollzeit

Quality System Specialist Job Description

We are seeking a Quality System Specialist to join our team at AliveDx. The successful candidate will be responsible for leading the implementation and transition of our Quality Management System from a manual or legacy system to an electronic Quality Management System (eQMS) in compliance with ISO 13485 standards.

Main Responsibilities

  • Lead the end-to-end transition to an electronic Quality Management System (eQMS), ensuring alignment with ISO 13485 requirements.
  • Work closely with IT, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless integration of the eQMS with existing processes and systems.
  • Ensure the eQMS meets ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory standards.
  • Oversee the validation and verification of the eQMS, including system qualification (IQ, OQ, PQ), user acceptance testing (UAT), and risk assessments.
  • Implement a comprehensive training program for end users, ensuring staff are proficient in the use of the new eQMS.

Requirements

  • Bachelor's degree in Quality assurance, Engineering, Life Sciences, Information Technology, or a related field and ideally advanced degree or certifications in Quality Management, Project Management (e.g., PMP), or Regulatory Affairs.
  • Minimum of 5 years of experience in quality management or project management roles within an ISO 13485-compliant environment, preferably in the medical device or pharmaceutical industry.
  • Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements for medical devices.
  • Experience in selecting, implementing, and validating eQMS platforms (e.g., MasterControl, TrackWise, or similar).

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