Senior Quality Assurance Lead

3 days ago


Malmo, Skåne, Sweden Nordberg Medical AB Full time
Job Summary:

Nordberg Medical AB is seeking a Senior Quality Assurance Lead to drive the development, optimization, and validation of manufacturing processes for our Class III medical devices. This is an exciting opportunity to lead cross-functional teams, improve efficiency and product quality, and ensure compliance with regulatory standards.

Key Responsibilities:

  • Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device products.
  • Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and process implementation.
  • Develop, document, and maintain process workflows, control plans, and SOPs.
  • Conduct process validation activities, including IQ/OQ/PQ.
  • Analyze and document validation results, addressing any deviations or non-conformances.
  • Collaborate with maintenance and equipment teams to ensure optimal performance of manufacturing equipment.
Requirements:
  • 5-8 years of experience in process engineering, with experience in Class III products.
  • Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or Manufacturing). A master's degree is a plus.
  • Proficiency in process design, documentation, and validation methodologies.
  • Strong understanding of GMP, ISO 13485, FDA 21, and other regulatory requirements.
  • Pharmaceutical cleanroom operations experience – Class A to C.
  • Freeze drying processes experience in the pharmaceutical industry, preferably EtO.
  • Fluent English communication skills.


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