Project Manager

Provide vision and leadership to strategic projects with significant site impact, ensure new products are launched from the site in alignment with contract goals, and manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams.

Requirements

• 5-7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry
• 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
• Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements
• Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle
• Bilingual (Spanish and English)