Operations Quality Engineer

TekniPlex; Clayton (NC); On-site; USD 69,000 - 87,000; Full time

Benefits offered by this job

Medical Coverage

Vision Coverage

401(k) Retirement Savings Plan

Life Insurance

Short Term Disability

Long Term Disability

Hospital Indemnity

Job summary

TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. The role ensures product quality and regulatory compliance (FDA 21 CFR Part 820, ISO 13485) across production, investigations, NPI, and transfers, with a salary range of $69,000 to $87,000 based on experience.

This position supports quality issues, customer complaints, CAPA, and continuous improvement while collaborating with Engineering, Regulatory, and Supply Chain to protect patient safety and product integrity.

Qualifications

• 3 to 5 years of experience in Quality Engineering or Manufacturing Quality in a regulated industry.
• Medical device experience 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).
• Experience with lean manufacturing or continuous improvement methodologies is a plus.

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.

Skills

Root cause analysis

Quality systems

Communication

Lean manufacturing

Education

Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field)

Tools

Statistical methods

Job description

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 TekniPlex, 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, TekniPlex Healthcare and TekniPlex 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 TekniPlex, you don’t just deliver products – you help shape what’s next.

JOB SUMMARY

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

DUTIES AND 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.

QUALIFICATIONS

• 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.

TekniPlex 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 assistance whenever you need it.

Some of your benefits are paid in full by TekniPlex and some costs are shared between you and TekniPlex. Other benefits are made available to you at reasonable group rates.

• Medical Coverage
• Prescription Drug Coverage
• Vision Coverage
• Employee Assistance Program
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Basic Term Life/AD&D Insurance
• Voluntary Life/AD&D Insurance
• Short Term Disability (STD)
• Long Term Disability (LTD
• Voluntary Buy-Up LTD
• Hospital Indemnity
• Critical Illness
• 401(k) Retirement Savings Plan
• Daily Pay
• Business Travel Insurance
• Legal Plan
• Identity Protection

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.

PHYSICAL DEMANDS

• On-site office work environment.
• 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.

Equal Opportunity Company

Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.