Batch Release and Quality Assurance Expert

7 days ago


Stockholm, Stockholm, Sweden Nordberg Medical Full time

Nordberg Medical is committed to providing high-quality products to our customers. To achieve this goal, we need a dedicated Quality Assurance Manager to oversee our quality assurance processes.

The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience in batch release processes, deviation management, and CAPA implementation. They will also possess excellent written and oral communication skills in English and proficiency in Swedish is desirable but not essential.

Key Responsibilities
  • Develop and Implement Quality Management Systems
  • Investigate Deviations and Conduct Root Cause Analyses
  • Lead CAPA and Complaints Investigation and Manage Implementation
  • Collaborate with Supply Chain, Sales, and CMOs to Ensure Regulatory Compliance
Required Skills and Qualifications
  • Bachelor's Degree in a Relevant Field (e.g., Engineering, Quality Assurance)
  • Around 3 Years of Experience in Quality Assurance within Production in the Medical Device or Pharmaceutical Industry
  • Strong Understanding of Regulatory and Medical Device Standards
  • Excellent Written and Oral Communication Skills in English
Other Information

This role can be based remotely or at our office in central Stockholm. Regular travel to our CMOs in Uppsala and Malmö will be needed.



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