QA/ra Associate

vor 2 Wochen

Zürich, Zürich, Schweiz Panda Vollzeit
At this moment, I am looking for a QA/RA manager to join a dynamic MedTech scale-up in Zurich.

This organisation is on an inspiring mission in the healthcare industry by improving the quality of care and they're currently in an exciting phase of growth.

In this role, you'll bring QA/RA to the next level by joining the QA/RA department. Next to that, you'll be part of the Management Team and be involved in the development of strategies.

MAIN RESPONSIBILITIES

  • Development and implementation of a strong and effective RA/QA strategy
  • Regulatory compliance (ISO 13485)
  • Define path to FDA 510(k) approval.
  • Further optimisation of the QM in terms of efficiency and fit with the organization.
  • Optimizing the Information Security Management System (ISO 27001)
  • Manage the process of design changes from a regulatory and compliance perspective.
  • Preparing and managing external and internal audits
  • Training the organisation on quality awareness, QMS, change management.

YOUR PROFILE

  • At least 4 years' experience with QA/RA in the Medical Device industry.
  • Indepth knowledge of MDR, ISO1348
  • Ideally, experience with FDA 510(k) approvals and Information Security Management System.
  • Able to lead the QA/RA team.
  • Excellent English verbal and written skills

ORGANISATION AND OFFER
This organisation is creating a healthcare system where all patients get the best possible treatments. Personalized care is where professionals learn at the same time.

You'll work in a growing and vibrant environment, dedicated to making health care smarter and better. They offer a competitive salary and benefits. Additionally, you are provided with many opportunities for personal development and to become part of the employee participation plan.

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