Quality System Engineer

vor 3 Wochen

Eysins, Schweiz AliveDx Vollzeit
Job Description

AliveDx is seeking a Quality System Engineer to join our Quality Assurance department based in Eysins, Switzerland. This is a full-time and temporary position for 12 months.

Key Responsibilities
  • Lead the successful implementation and transition of the company's Quality Management System from a manual or legacy system to an electronic Quality Management System (eQMS) in compliance with ISO 13485 standards.
  • Lead the integration of Medical Device Single Audit Program (MDSAP) requirements into the company's existing Quality Management System (QMS), which complies with ISO 13485 standards.
  • Manage the project to ensure the organization meets the regulatory requirements of MDSAP-participating countries (e.g., USA, Canada, Brazil, Australia, and Japan) to reach the successful MDSAP certification.
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).
  • Experience with validation and compliance of computerized systems (e.g., GAMP 5, 21 CFR Part 11).
What We Offer
  • A highly dynamic and growing environment.
  • An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
  • A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.

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