Quality Engineer

Katalyst HealthCares & Life Sciences

Full-time Engineers
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Location
Framingham, Massachusetts, United States
Posted
June 30, 2026

Job Description


Responsibilities:
  • Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO , ISO , and regulatory requirements including FDA regulations.

  • Conduct regular quality audits across manufacturing processes to identify areas for improvement and ensure compliance with internal policies and external standards.

  • Perform detailed quality inspections and control checks at various stages of production to verify product specifications and detect deviations.

  • Collaborate with cross-functional teams to establish quality assurance protocols that support manufacturing efficiency while maintaining product integrity.

  • Lead root cause analysis investigations for non-conformances or product defects; develop corrective and preventive actions (CAPA) to address issues effectively.

  • Support validation activities for manufacturing equipment and processes in accordance with CG...