Senior Quality Systems Manager

4 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Nordberg Medical is seeking a highly skilled Senior Quality Systems Manager to join our team in Stockholm, Sweden. As a key member of our quality department, you will be responsible for ensuring the quality of our implantable Class III medical devices through the development, implementation, and maintenance of quality management systems.

Responsibilities:
  1. Quality Management System: Develop, implement, and maintain quality management systems that meet regulatory requirements and industry standards.
  2. Process Validation: Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
  3. Root Cause Analysis: Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.

Requirements: Bachelor's degree in Engineering or a related field and minimum 5 years of experience in quality management and regulatory compliance.



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