Teams at TekniPlex

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.

Supports recruitment, onboarding, and employee integration by coordinating with staffing agencies, scheduling interviews and orientations, conducting new employee orientation, maintaining personnel and training records, addressing time/attendance and employee inquiries, coordinating engagement events and communications, and providing general HR administrative support.

The Operations Quality Engineer ensures product quality and regulatory compliance in a medical device manufacturing environment. Responsibilities include investigating complaints and nonconformances, implementing corrective actions, supporting NPI and product transfers, validating processes and test methods, training operators, supporting audits, analyzing quality metrics, and leading continuous improvement initiatives. The role collaborates with Engineering, Production, Regulatory, and Supply Chain teams.