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Medical Device Quality Assurance Expert

2 weeks ago

Malmo, Skåne, Sweden g2 Recruitment Full time

**Job Overview:**

We are seeking a highly skilled Quality Engineer to join our team at g2 Recruitment. As a Quality Engineer, you will play a critical role in ensuring compliance with international quality standards in the development of medical devices for drug delivery systems.

The successful candidate will work closely with R&D, manufacturing, and regulatory teams to uphold quality and drive continuous improvement throughout the product development lifecycle.

  • Key Responsibilities:
  • Ensure compliance with FDA, ISO 13485, and other relevant standards.
  • Conduct risk assessments and support design control activities.
  • Maintain and review documentation for regulatory compliance.
  • Collaborate on process improvements and manage supplier quality.
  • Support audits and change management processes.

Requirements:

  • Bachelor's degree in Engineering or a related field.
  • 3+ years of experience in quality engineering (medical device or pharma).
  • Knowledge of ISO 13485, FDA regulations, and risk management.
  • Strong communication and problem-solving skills.
  • Experience with drug/device combination products is a plus.