TekniPlex Benefits Overview

Ensures product quality and regulatory compliance in a medical-device manufacturing environment. Leads quality issue, customer complaint, and NCMR investigations; supports CAPA, NPI, product transfers, process validation, audits, operator training, risk management, and continuous improvement. Analyzes quality metrics and collaborates with Engineering, Production, Regulatory, and Supply Chain teams to resolve issues and maintain compliant, capable manufacturing processes.

Operate and set up extrusion lines, perform frequent quality checks, verify materials and packaging, complete ISO/GMP/HACCP documentation, produce labels, assign lot numbers, minimize scrap, and troubleshoot equipment. Responsibilities include cleaning and inserting extruder screws, disassembling and reassembling tooling, operating pulling and cutting equipment, and replacing cutter components while following safe work practices.

Leads quality management systems and quality teams across multiple medical device manufacturing sites. Responsibilities include ensuring ISO and FDA compliance, standardizing quality initiatives, supporting technology transfers and validation activities, managing audits, resolving customer quality issues through root cause analysis and corrective actions, driving continuous improvement, and coaching quality personnel. The role is onsite five days per week in Ridgefield, NJ and requires up to 25% travel between sites.