Jobs at TekniPlex

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.

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.

The Quality Manager oversees the site Quality Management System, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and customer requirements. Responsibilities include managing complaints, nonconforming materials, CAPA, QA documentation, process validation, audits, management reporting, quality improvements, customer communications, budgeting, and team leadership. The role develops and mentors the Quality team while promoting a strong quality culture across the manufacturing facility.

Receive and release rail cars, unload resin into designated silos, monitor silo levels and vacuum systems, operate railcar valves and manifolds, collect samples, complete documentation, troubleshoot equipment, maintain filters and pumps, and support inventory and production activities. The role requires outdoor work in varying weather, fall protection on railcars, compliance with safety, environmental, HACCP, and GMP requirements, and the ability to work independently.

Performs entry-level accounting activities under Controller supervision, including balance sheet reconciliations, journal entries, monthly workpapers, transaction research, AP vendor GL coding, inventory cycle counts, budgeting, audit support, and fixed asset recordkeeping. The role requires knowledge of GAAP, strong analytical and mathematical skills, accurate documentation, effective communication, and proficiency with Microsoft Office. Manufacturing accounting experience and ERP knowledge are preferred or advantageous.

Leads technical manufacturing operations for medical packaging, including product and equipment validation, raw material qualification, formulation and process optimization, equipment commissioning, regulatory compliance, and customer engineering support. Manages pre-press and graphics functions while leading, mentoring, and developing technical and engineering teams. Partners with plant leadership and cross-functional stakeholders to drive innovation, quality, safety, repeatability, and operational performance.

Coordinate purchasing from requisition through purchase order completion. Manage supplier communications, obtain quotes, monitor orders and inventory levels, track shipments, resolve discrepancies, support vendor onboarding and contract administration, prepare procurement reports, and collaborate with finance, warehouse, and operations.

Lead New Product Development and New Product Introduction projects by supervising engineers, coordinating with operations, and ensuring project milestones are met while improving safety, quality, and productivity.

Manage R&D projects for implant and catheter-based systems: plan, staff, schedule, and budget projects; define product and engineering specifications; develop and optimize designs/processes; coordinate project personnel and customer communications; prepare reports; support design/process improvements and manufacturing documentation.

Lead category strategy and strategic sourcing for indirect functional spend (HR, IT, Marketing, Insurance, Professional Services). Manage a ~$60M global portfolio, drive cost savings, supplier consolidation, and risk mitigation. Own supplier relationships, contract compliance, procurement governance, stakeholder collaboration across functions and divisions, and track/ report value delivery into the central procurement pipeline.

The Senior Pricing Manager will lead the transformation of pricing across the organization, develop pricing strategies, ensure compliance, and partner with various departments to align pricing with business objectives.

Join TekniPlex's talent community to stay connected for future opportunities across various fields, contributing to innovative material solutions.

Lead HR activities across multiple manufacturing sites: talent acquisition, labor relations (including unions), performance management, payroll oversight, benefits administration, compliance, onboarding, leadership development, and employee engagement. Partner with plant leaders and HR COEs to drive workforce planning, coach leaders, implement people metrics, and foster a positive, inclusive culture.

The Global Key Account Manager oversees strategic global accounts, driving sales and profitability while building relationships and developing proposals. This role involves financial planning, team leadership, and negotiating supply contracts to enhance customer satisfaction and business growth.

Support design, testing, and manufacturing for assigned product development projects. Define and document customer and engineering specifications, perform testing and analysis, track milestones and project hours, create control documentation, support manufacturing methods, mentor other engineers, and ensure deliverables meet customer requirements and deadlines.

Supervise night-shift production operations (rotating 2/2/3) leading 40+ employees to meet safety, quality, cost, schedule, and profitability targets. Hire, train, coach, and mentor leads and crew; maintain shift records, ensure SQF/HACCP compliance, drive process improvements, collaborate cross-functionally, and manage departmental budgets and goals.

Lead development and commercialization of new rubber products: design, costing, lab testing, pilot trials, scale-up, documentation, quality and regulatory compliance, and technology transfer to manufacturing while supporting customer and supplier interactions.