Medical Device QA Specialist

5 days ago


Uppsala, Uppsala, Sweden Nordberg Medical Full time
Overview of the Role:

At Nordberg Medical, we are seeking a skilled Quality Assurance Specialist to join our team. This individual will play a vital role in ensuring the quality and safety of our products by managing all aspects of QA within the manufacturing process.

The ideal candidate will possess excellent communication and problem-solving skills, as well as a deep understanding of regulatory requirements and quality management systems.

Responsibilities:
  • Oversee the review and release of batch records.
  • Investigate and resolve deviations and non-conformities in collaboration with internal stakeholders and contract manufacturers.
  • Develop and implement effective Corrective and Preventive Actions (CAPA) to prevent future occurrences.
  • Contribute to the development of our Quality Management System (QMS).
  • Communicate effectively with cross-functional teams to ensure seamless execution of QA processes.
Requirements:
  • Bachelor's degree in a relevant field, such as Engineering or Quality Assurance.
  • Minimum 3 years of experience in QA within the medical device or pharmaceutical industry.
  • Excellent written and oral communication skills in English. Proficiency in Swedish is desirable.
  • Strong understanding of quality management systems and regulatory requirements.


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