This search has been filled. ETHOSLINK completed this retained search and it is no longer accepting applications. The brief stays here as a record of the work.
Charlotte Metro, NC (On-site)
Full-time
Quality leadership across the full product lifecycle for a manufacturer operating in regulated life-sciences markets. This seat owns quality strategy from new product introduction through supplier development and QMS integration — building the supplier capability and validation discipline that lets the business scale into regulated markets without trading away compliance.
What the seat owned
Establish and lead Advanced Product Quality Planning (APQP) frameworks tailored for regulated industries, and define quality strategy aligned to business growth and new market expansion
Drive risk-based methodologies — FMEA, CTQs, and control plans — across product and process development
Own quality execution across the full NPI lifecycle: concept, design, validation, launch, and post-launch monitoring
Oversee design controls, technical reviews, and process validation (IQ/OQ/PQ), ensuring robust design transfer into manufacturing and the supply chain
Drive First Article Inspection (FAI) and PPAP development, and improve Right First Time (RFT) and First Pass Yield (FPY) on new product launches
Build and execute a strategic supplier development program, engaging suppliers early in NPI for design for manufacturability, process capability, and risk mitigation on critical components
Own supplier qualification and onboarding — audits, capability assessments, and validation alignment — with segmentation across strategic, critical, and transactional suppliers
Deploy supplier quality tools: supplier APQP, PPAP/FAI, supplier FMEA, and supplier control plans
Manage supplier performance against PPM, on-time delivery, and Cost of Poor Quality, driving corrective action through structured methodologies (8D, DMAIC)
Integrate NPI and supplier development into the QMS in alignment with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 — standardizing design control, change management, and CAPA procedures
Maintain audit readiness across internal operations and the full supplier base
Partner with Regulatory Compliance on product and material compliance (RoHS, REACH, CMRT, PFAS) and monitor evolving requirements affecting products and suppliers
Lead cross-functional collaboration across Engineering, Manufacturing & Operations, Supply Chain & Procurement, and Regulatory Compliance, including co-development with key suppliers and customers
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