Quality Engineer for Medical Devices

17 hours ago


Malmo, Skåne, Sweden g2 Recruitment Full time

About the Role:

The successful candidate will have a strong background in quality engineering and be able to work closely with R&D, manufacturing, and regulatory teams to ensure quality and drive continuous improvement throughout the product development lifecycle.

Responsibilities:

  • Comply with FDA, ISO 13485, and other applicable standards.
  • Risk assessment and design control activity support.
  • Ongoing documentation review for regulatory compliance.
  • Process enhancements and supplier quality management collaboration.
  • Audit and change management support.

Requirements:

  • Engineering or related field bachelor's degree.
  • Minimum 3 years' experience in quality engineering (medical device or pharmaceutical).
  • Familiarity with ISO 13485, FDA regulations, and risk management principles.
  • Excellent communication and analytical skills.
  • Preferably experienced with combination drug-device products.


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