Impactful Operations Quality Engineer (Medical Devices)

Tekni-Plex, Inc.; Clayton, Northern (NC, KY); Hybrid; USD 69,000 - 87,000; Full time

Benefits offered by this job

Medical Coverage

Vision Coverage

401(k) Retirement Savings Plan

Life Insurance

Job summary

TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. This role ensures product quality and regulatory compliance within the manufacturing environment, including FDA 21 CFR Part 820 and ISO 13485.

You will support production operations by managing quality issues, investigations, and continuous improvement to ensure consistent quality and process performance. Join a global team of problem-solvers across healthcare and consumer products, with opportunities to lead

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 3–5 years in Quality Engineering in regulated industry; medical device preferred.
• Familiar with FDA 21 CFR Part 820 and ISO 13485 quality systems.
• Experience with NCMR, CAPA, complaints and production support.

Responsibilities

• Lead quality issue management in Operations, including investigations and containment.
• Perform and support supplier/client complaint investigations with root cause analysis.
• Support NCMR investigations, disposition, and documentation.
• Assist NPI and product transfer signoffs for manufacturing readiness.
• Provide operator training on quality standards and procedures.
• Drive quality metrics data analysis and reporting.

Skills

Quality engineering

Root cause analysis

Lean manufacturing

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. This role ensures product quality and regulatory compliance within the manufacturing environment, including FDA 21 CFR Part 820 and ISO 13485.

You will support production operations by managing quality issues, investigations, and continuous improvement to ensure consistent quality and process performance. Join a global team of problem-solvers across healthcare and consumer products, with opportunities to lead