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Healthtech • Manufacturing
Develops and maintains quality engineering systems, methodologies, and practices for medical manufacturing and new product process development. Ensures products comply with customer expectations, GMP requirements, international quality standards, and medical product regulations. Leads process improvement, risk management, validation, root cause analysis, problem solving, business process deployment, training, and quality support for manufacturing operations.
Healthtech • Manufacturing
Develops and maintains quality engineering systems for medical manufacturing and new product development. Leads product testing, validation, risk analysis, regulatory compliance, process improvement, and quality issue resolution. Supports FDA, ISO, MDD, and GMP requirements; maintains regulatory files and quality systems. Serves as a quality subject matter expert, drives corrective actions, and ensures validated manufacturing processes and accurate device records meet customer and regulatory expectations.
Healthtech • Manufacturing
Develops and validates manufacturing processes for rotary converting products, including prototyping, equipment and tooling selection, design for manufacturability, process troubleshooting, product and press drawings, and IQ/OQ/PQ documentation. Leads development projects through production transfer while meeting quality, cost, delivery, safety, and reproducibility goals. Collaborates with customers, suppliers, manufacturing, sales, quality, and consultants, applying Lean Six Sigma, GMP, ISO 13485, statistical methods, and scientific process-development techniques.



