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.
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.
- 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
- Telemedicine
- Dental 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
- Accident Insurance
- 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.
