Spectrum Plastics Group Benefits Overview

Leads cross-functional medical device product development and commercialization programs from opportunity assessment through launch. Manages integrated plans, budgets, risks, stage-gate governance, customer relationships, regulatory and design-control compliance, technology transfer, and manufacturing commercialization. Coordinates engineering, operations, quality, regulatory, supply chain, commercial, and customer stakeholders while supporting business growth and continuous improvement.

Supports quality and regulatory activities for sustaining products, including process improvements, risk management, complaint investigations, CAPA, design controls, validations, audits, nonconforming materials, and quality-system documentation. Serves as a quality representative and potential process owner while partnering with Engineering and cross-functional teams. Applies statistical analysis, root-cause investigation, FDA QSR, and ISO 13485 requirements to improve manufacturing processes and product quality.

Leads complex medical device product development and commercialization programs from opportunity assessment through launch. Coordinates cross-functional engineering, quality, regulatory, manufacturing, supply chain, commercial, and customer teams; manages integrated plans, risks, budgets, governance, compliance, technology transfer, and financial performance. Builds customer relationships, supports business growth, and drives scalable manufacturing and continuous improvement across global sites.