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Quality Assurance Specialist

2 months ago

Boston, Massachusetts, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to lead our quality assurance activities and drive process improvements. As a key member of our team, you will be responsible for ensuring the highest levels of quality in our products and processes.

Key Responsibilities
  • Technical Leadership: Provide technical leadership and direction in quality assurance, quality control, and preventative activities to ensure compliance with regulatory requirements and industry standards.
  • Process Development: Develop and characterize processes that are capable, scalable, and produce high yield, while ensuring robust inspection strategies and process risk management.
  • Quality Systems Development: Support the development and introduction of new products, processes, and technologies, with a focus on quality systems development, regulatory compliance, and process risk management.
  • Supplier Qualification: Lead the supplier qualification strategy and approve supplier validations and Production Part Approval Process (PPAP).
  • Communication: Communicate effectively with internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
Requirements
  • Education: Bachelor's degree in Manufacturing, Industrial Engineering, or a related field.
  • Experience: Previous experience in engineering or project management, with a minimum of [insert number] years of experience in quality assurance and process improvement.
  • Skills: Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes (PFMEA). Experience in ISO-certified and cGMP organizations preferred.