Quality Assurance Manager

5 days ago


Uppsala, Uppsala, Sweden TN Sweden Full time

We are looking for a highly skilled Quality Assurance Manager to join our team in Uppsala, Sweden.

About the Role:

The ideal candidate will have extensive experience in quality assurance, with a strong understanding of industry best practices and regulatory requirements.

Key Responsibilities:
  1. Develop and implement quality assurance processes to ensure compliance with regulatory requirements.
  2. Collaborate with cross-functional teams to drive continuous improvements in the quality assurance process.
  3. Provide expertise and support during audits, inspections, or inquiries from regulatory authorities.
  4. Identify, assess, and mitigate risks associated with medical device development.
  5. Develop and update quality assurance documentation, including quality manuals, procedures, and records.
Required Skills and Qualifications:
  • Master's or Bachelor's degree in Life Sciences or related discipline.
  • Several years of experience in quality assurance within the Life Science Industry.
  • Fluent in English with strong written and verbal communication skills.
  • Experience with GMP is required.
  • Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.
  • Desired knowledge in Risk Management ISO 14971/ISO 24971 and Usability IEC 62366 for Medical Devices.
  • Advantageous to have experience in device development and leading cross-functional teams across various functions such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial.


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