Quality Planning & Supplier Development (New Product Introduction)
Core
Lead Advanced Product Quality Planning (APQP) and supplier development for new product introductions in regulated industries.
Role type
Senior Quality Planning & Supplier Development Manager
Builds
New product launches and supply chain capabilities for Biopharma, Lab, and Medical Devices
Domain
Manufacturing Quality / Regulated Industries (Biopharma, Medical Devices)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced Product Quality Planning (APQP), Failure Mode and Effects Analysis (FMEA), Process Validation (IQ/OQ/PQ), First Article Inspection (FAI), PPAP, Supplier Auditing, Risk Management, Root Cause Analysis (8D, 5 Whys), Statistical Process Control (SPC), Project Management
Preferred skills
Six Sigma Black Belt, ISO 13485, FDA 21 CFR Part 82, Strategic Supplier Segmentation
Technologies
ISO 9001, ISO 13485, FDA 21 CFR Part 82, SPC, 8D, DMAIC
Responsibilities
Establish APQP frameworks for regulated industries, drive risk-based methodologies across product development, lead supplier qualification and onboarding, ensure design transfers into manufacturing, manage supplier performance metrics (PPM, OTD, COPQ), ensure regulatory compliance (ISO 13485, FDA), lead corrective actions and continuous improvement with suppliers.
Seniority
Senior, hands-on IC with strategic oversight
