Quality Engineer - Medical Device Operations

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

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.