Quality Engineer (m/w/d) ISO 13485

location_onWinterthur, Schaffhausen
work_outlineFestanstellung

Copy Linklink

Our client is an internationally active company with a strong reputation as a system supplier for the medical packaging industry. From design and film production to blister manufacturing, machine engineering, and full packaging services – everything comes from a single source.

Why This Role?


  • Be part of a fast-evolving international MedTech environment where quality directly impacts healthcare outcomes.
  • Take ownership of quality and regulatory processes and become a key player in ensuring compliance and continuous improvement.
  • Collaborate across teams and with external partners – your input will make a visible difference.
  • Join a company culture that values initiative, precision, and innovation – with room to grow professionally.


Your Key Responsibilities


  • Lead quality management processes: audits, CAPAs, supplier qualification, risk management, and document control.
  • Drive regulatory compliance, ensuring all standards (ISO 13485 and similar) are met.
  • Implement quality objectives and help shape the future of the company’s ISO 13485 management system.
  • Improve and develop processes to increase efficiency and maintain the highest industry standards.
  • Train and support colleagues, promoting a strong culture of quality across the organization.





What You Bring


  • A practical, solution-driven mindset with the motivation to take ownership and make things happen.
  • 5+ years of experience in Quality Management under ISO 13485 or related standards.
  • A solid technical background and ideally further training in quality management.
  • Strong understanding of medical packaging regulations and industry standards.
  • Analytical and problem-solving skills paired with a structured, precise working style.
  • German fluent and English fluent.
  • Experienced in MS Office and ERP systems.


What’s in It for You

  • A responsible role with real impact in the MedTech industry.
  • The chance to shape processes and influence company-wide quality standards.
  • An international, innovative environment where your ideas are valued.
  • A company culture that encourages ownership, collaboration, and continuous development.




Are you looking for a new challenge? Do not hesitate and APPLY NOW!

Ref: JN-082025-832534