Quality Planning & Supplier Development (New Product Introduction)
Core
Lead Advanced Product Quality Planning (APQP) and supplier development for New Product Introduction (NPI) in regulated industries like Biopharma and Medical Devices.
Role type
Senior Quality Planning & Supplier Development Manager
Builds
New product launches and robust supply chain quality systems
Domain
Manufacturing / Biopharma / Medical Devices
Required skills
APQP, PPAP, FMEA, Control Plans, Root cause analysis (8D, 5 Whys), Statistical analysis (SPC, Cp/Cpk), Supplier auditing, Risk management, Project management
Preferred skills
Six Sigma Black Belt, ISO 13485, FDA regulations (21 CFR Part 82), Strategic supplier partnership
Technologies
SPC, Cp/Cpk, ISO 9001, ISO 13485
Responsibilities
Establish APQP frameworks for regulated industries, Lead supplier qualification and onboarding, Drive First Article Inspection (FAI) and PPAP development, Ensure compliance with FDA and ISO standards, Manage supplier performance metrics (PPM, On-time delivery), Collaborate with Engineering and Supply Chain on NPI lifecycle
Seniority
Senior, hands-on IC
