Project Manager - NPI
FITS LLC, Dorado, Dorado, United States
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.
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.
The Personality Part
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
As a piece of fit, you will
Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
Project / Program Management: Lead initiation, planning, execution, control, and closeout activities; ensure team ownership of plans, schedules, and budgets.
Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.
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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.
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.
The Personality Part
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
As a piece of fit, you will
Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
Project / Program Management: Lead initiation, planning, execution, control, and closeout activities; ensure team ownership of plans, schedules, and budgets.
Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.
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