Operations Quality Engineer

About the Role

TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. You’ll join a global team of problem-solvers whose innovations in materials science improve patient outcomes in healthcare and protect essential consumer goods. As part of a company with over 8,000 colleagues across 12 countries, you’ll help shape industries that matter—healthcare, pharmaceutical, food & beverage, beauty, and personal care—by ensuring product quality and compliance within the manufacturing environment in accordance with 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.

Responsibilities

• 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.
• Perform test method validations.
• 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.

Requirements

• 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 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.

Skills

• Language Skills: Strong verbal and written communication skills in English required. Ability to read and interpret technical drawings, specifications, procedures, and regulatory documents. Ability to communicate effectively with production operators, engineers, and cross-functional teams.
• Mathematical Skills: Ability to apply statistical methods, basic algebra, and data analysis techniques. Ability to interpret quality data, trends, and process capability metrics.

Pay

This position offers an annual salary range of $69,000 to $87,000, based on experience and qualifications.

Benefits

TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs, including:

• Medical, prescription drug, dental, and vision coverage
• Telemedicine
• Employee Assistance Program
• Health Savings Account (HSA) and Flexible Spending Account (FSA)
• Basic Term Life/AD&D Insurance and voluntary life/AD&D options
• Short Term Disability (STD), Long Term Disability (LTD), and voluntary buy-up LTD
• Hospital indemnity, accident insurance, and critical illness coverage
• 401(k) Retirement Savings Plan
• Daily Pay
• Business Travel Insurance
• Legal Plan and Identity Protection

Some benefits are paid in full by TekniPlex, while others are shared or available at group rates.

Physical Demands

• On-site office work environment with occasional walking within manufacturing or production areas.
• Ability to sit or stand for extended periods while working on a computer.
• Occasional lifting up to 10–15 lbs.

Work Environment

• Work is performed in a regulated medical device manufacturing environment.
• Exposure to production areas may require use of personal protective equipment (PPE).
• Standard office conditions with occasional time spent in manufacturing or cleanroom areas.
• Must comply with all safety and quality system requirements.