Operations Quality Engineer

TekniPlex•Clayton, NC

23h•Onsite

About The Position

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.

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 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.
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.
Ability to apply statistical methods, basic algebra, and data analysis techniques.
Ability to interpret quality data, trends, and process capability metrics.

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.