Project Manager - New Product Introduction
Flexible & Integrated Technical Services, LLC • Dorado, Puerto Rico
Role Description
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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