Operations Quality Engineer

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 an Operations Quality Engineer for our Clayton, NC facility. The role is responsible for ensuring product quality and compliance within the manufacturing environment in accordance with applicable regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485. This role supports production operations by managing quality issues, investigations, new product introductions (NPI), product transfers, and continuous improvement initiatives to ensure consistent product quality and process performance.

• Lead and support quality issue management activities within Operations, ensuring timely investigation, containment, and resolution.
• Perform and support customer complaint investigations, including root cause analysis and corrective action implementation.
• Lead and/or support nonconformance material report (NCMR) investigations, including disposition and documentation.
• Support NPI and product transfer signoffs, ensuring manufacturing readiness and compliance with quality requirements.
• Provide Operator training support, ensuring production personnel are trained on quality standards, procedures, and product requirements.
• Support Manufacturing Operating System (MOS) initiatives and daily production quality activities.
• Lead and support continuous improvement projects in collaboration with Engineering and Operations teams.
• Participate in process validations, risk management activities, and quality planning as required.
• Ensure compliance with internal procedures, regulatory standards, and customer requirements.
• Support internal and external audits as needed.
• Drive data analysis and reporting of quality metrics, trends, and performance indicators.
• Collaborate with cross-functional teams including Engineering, Production, Regulatory, and Supply Chain to resolve quality-related issues.

• Bachelor’s degree in engineering (Mechanical, Industrial, Biomedical, or related field) preferred.
• 3 to 5 years of experience in Quality Engineering or Manufacturing Quality in a regulated industry
• Medical device strongly preferred.
• Knowledge of quality system principles as outlined in either FDA 21 CFR Part 820 and/or ISO 13485.
• Experience with NCMR, complaint handling, CAPA, and production support activities.
• Familiarity with NPI and product transfer processes is highly preferred.
• Strong problem-solving and root cause analysis skills (e.g., 5 Why, Fishbone, etc.).
• Experience with lean manufacturing or continuous improvement methodologies is a plus.

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 benefits provide support and…