Quality Assurance Manager for Medical Devices

hace 6 horas


Tijuana, Baja California, México Ch01 Che Fresenius Medical Care (Schweiz) Ag A tiempo completo

About the Role:

Ch01 Che Fresenius Medical Care (Schweiz) Ag is seeking an experienced Quality Assurance Manager to join its team. In this critical role, you will be responsible for managing and developing the company's quality system, ensuring compliance with medical industry regulations and standards.

Key Responsibilities:

The ideal candidate will have a strong background in quality assurance, preferably in the medical industry. Key responsibilities include:

  • Developing and implementing quality policies, procedures, and methodologies
  • Maintaining and updating quality systems, including ISO 13485-2016 certification
  • Ensuring compliance with product specifications and quality system requirements
  • Leading audits, investigations, and corrective actions
  • Coordinating preparation activities for external audits
  • Reporting to senior management on quality system performance
  • Collaborating with cross-functional teams to drive continuous improvement

Requirements:

To be successful in this role, you will need:

  • A minimum of 7 years of experience in quality assurance, preferably in the medical industry
  • At least 5 years of supervisory experience
  • A bachelor's degree in industrial engineering, chemical engineering, mechanical engineering, electrical engineering, or a related field
  • Advanced knowledge of medical industry regulations and standards, including ISO 13485-2016
  • Proficiency in quality management and administration tools
  • Lead auditor ISO 13485-2016 certification

What We Offer:

We offer a competitive salary of CHF 120,000 - 180,000 per annum, depending on experience, as well as a range of benefits, including:

  • Health insurance
  • Retirement savings plan
  • Generous paid time off
  • Ongoing training and development opportunities

Join Our Team:

As a key member of our quality team, you will have the opportunity to make a real impact on our business and contribute to the delivery of high-quality products to our customers. If you are passionate about quality assurance and have the skills and experience we are looking for, please apply today.



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