For  Project Management Services.

WHAT MAKES YOU A FIT:  The Technical Part: Bachelor’s Degree in Engineering or Science.

Five - Seven (5–7) years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry Bilingual: Spanish and English Soft Skills: Attention to detail, organization, and writing skills  Shift: Administrative and according to business Experience: Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.

Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.

Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.

Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.

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