Quality Manager

Imagine: A Career with Purpose and Possibility

Picture this:
You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact using science, technology, and creativity to tackle real-world challenges. You are part of a company whose work helps improve patient outcomes in healthcare and protects essential consumer goods that people around the world rely on every day.

At Tekni Plex, you’ll join more than 8,000 colleagues across 12 countries, all united by one purpose: creating safer, smarter solutions that touch daily life. Through our two divisions, Tekni Plex Healthcare and Tekni Plex Consumer Products, you’ll help shape industries that matter: healthcare, pharmaceutical, food & beverage, beauty, and personal care.

Here, your ideas count and your work matters. You’ll be encouraged to think boldly, collaborate across cultures, and keep growing every step of the way. You will help protect the integrity of essential products, support patient safety and comfort, and contribute to innovations that make everyday life better, all while building a career that makes an impact.

Because at Tekni Plex, you don’t just deliver products – you help shape what’s next.

Tekni Plex is hiring a Quality Manager for our Clayton, NC facility. The Quality Manager works to deliver consistent quality of performance through the management of an effective Quality Management System, promotes a strong Quality culture within the business, and develops, through coaching and mentorship, the skills and experience of the Quality team. This position offers an annual salary range of $110,000 to $138,000, based on experience and qualifications.

Relocation assistance is available for qualified candidates.

• Acts as the Management representative for the site and is responsible for the overall effectiveness of the site QMS processes in line with the requirement of 13485:2016.
• Manage customer complaints process, non-conforming material process and CAPA (Corrective and Preventive Action) implementation, and associated follow-up activities.
• Develop, review, and approve QA documentation as related to general QA activities required within the site.
• Report on QMS performance to top management and recommend improvements based on trends and analysis of process performance.
• Develop strong customer relationships through professional, constructive, proactive communication on product, process and system quality requirements including change notifications and responsiveness to quality concerns.
• Ensure all manufacturing processes are verified or validated, monitored, and maintained in and maintained in line with customer requirements, FDA 21 CFR 820, ISO 13485, and other applicable regulations.
• Lead internal and external audit programs, including notified body inspections.
• Build, mentor, and lead a high-performing Quality team, support their professional development and ensure alignment within the team against business objectives.
• Champion a Quality culture of Customer focus, proactively identifying and implementing process improvements and quality best practices across the business
• Manages the Quality budget and works with site management to deliver business objectives.

• Bachelor’s degree in engineering, Business degree with a strong quality focus, or similar degree
• 10+ years of quality assurance management experience
• Experience working within FDA 21 CFR Part 820 and ISO 13485 regulated environments is required
• Strong understanding of statistics, quality equipment, instruments and processes
• Good communication and interpersonal skills using tact and diplomacy
• Exceptional attention to detail
• Must be self-directed with leadership qualities
• Ability to travel up to 15%

Tekni Plex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer you and your family health care coverage and financial security. You can take advantage of life insurance, disability coverage and voluntary benefits for extra financial protection and peace of mind. Plus, our work-life…