Manufacturing Process Lead

21 hours ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Nordberg Medical seeks a highly skilled Manufacturing Process Lead to join our team in Stockholm, Sweden. As a key member of our production department, you will be responsible for leading the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.

Key Responsibilities:
  1. Process Design and Development: Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
  2. Collaboration and Communication: Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
  3. Documentation and Maintenance: Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).

Regulatory Compliance and Documentation: Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.

Requirements:
  • Bachelor's degree in Engineering or a related field.
  • Minimum 5 years of experience in manufacturing process development and implementation.
  • Strong understanding of quality management systems and regulatory requirements.


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