Job Description

SUMMARY: 

The Quality Engineer supports and strengthens the company’s Quality Management System (QMS) by evaluating, improving, and implementing processes that ensure compliance with applicable regulations and internal standards. This role partners closely with internal teams and external partners—including Contract Manufacturing Organizations (CMOs) and third‑party service providers—to maintain quality oversight, drive continuous improvement, and support inspection readiness. The Quality Engineer also contributes technical expertise to investigations, audits, and data‑driven quality decisions. Periodic travel is required (up to 20% annually). 

ESSENTIAL FUNCTIONS: 

Quality Systems & Documentation 

  • Develop, revise, and implement quality procedures and controlled documents to support an efficient and compliant QMS.
  • Initiate, review, and approve Change Controls and ensuretimelyclosure of quality records (deviations, CAPAs, complaints, etc.).
  • Pr...

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