Manufacturing Quality Engineer

Job Title:

Quality Engineer – Medical Devices

Location:

North Carolina, NC Job Summary

The Quality Engineer is responsible for ensuring compliance with applicable regulatory requirements and quality system standards throughout the product lifecycle. This role supports manufacturing, design, and supplier quality activities to ensure medical devices are safe, effective, and compliant with FDA, ISO, and other global regulatory requirements.

• Ensure compliance with ISO 13485
  , 21 CFR Part 820 (FDA QSR), and applicable global regulatory standards.
• Support and maintain the Quality Management System (QMS), including SOPs, work instructions, and records.
• Lead and support CAPA
  , Nonconformance
  , and Deviation investigations using root cause analysis tools (5 Why, Fishbone, etc.).
• Conduct and support internal audits
  , supplier audits, and regulatory inspections.
• Review approve Design History File (DHF),
  Device Master Record (DMR), and Device History Record (DHR) documentation.
• Support risk management activities in accordance with ISO 14971
  .
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality issues.
• Support process validation
  , equipment qualification
  , and change control activities.
• Analyze quality data and metrics to drive continuous improvement initiatives.
• Ensure proper handling of complaints
  , returns
  , and field actions as required.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 2–5+ years of Quality Engineering experience in the medical device industry
  .
• Strong working knowledge of ISO 13485
  , FDA QSR (21 CFR 820), and GMP requirements.
• Experience with CAPA
  , NC
  , Change Management
  , and Risk Management
  .
• Familiarity with statistical tools and quality methodologies.
• Strong documentation, communication, and problem-solving skills.

• Experience with FDA audits
  , Notified Body audits
  , or global regulatory inspections.
• Knowledge of MDR / IVDR requirements (EU).
• Certification such as ASQ CQE
  , CQA
  , or equivalent.
• Experience with supplier quality management.