Quality Manager (m/f/d)

Project details:

• Project start: 15.07.2026
• Project duration: 6 months (possible extension)
• Location: Switzerland, 3 days on-site, 2 days HO

Tasks:

• Manage and maintain the Quality Management System (QMS) for Medical Devices in compliance with ISO 13485, FDA 21 CFR Part 820
• Oversee the implementation and maintenance of policies and procedures related to quality management and control, including document control, change control, risk management, supplier quality, and complaint handling
• Monitor and evaluate the effectiveness of the QMS through metrics and internal audits
• Provide leadership and guidance to the Quality Systems team and cross-functional teams to ensure quality objectives are met and maintained
• Ensure compliance with all applicable laws, regulations, and industry standards related to Medical Devices
• Collaborate with Regulatory Affairs, R&D, Manufacturing, and other departments to ensure quality requirements are incorporated into product development, production, and post-market activities
• Participate in regulatory inspections and support resolution of any quality-related issues 

Qualifikationen:

• Bachelor's or Master's degree in Engineering, Life Sciences, or Mechatronics
• Minimum of 7 years of experience in Quality Systems management within Medical Devices, including knowledge of ISO 13485, ISO 90001
• Experience in conducting internal and external audits and supporting regulatory inspections and hands-On Mentality
• Notified body experience
• Excellent communication, leadership, and problem-solving skills. Strong attention to detail and ability to prioritize tasks in fast paced environment