Quality Engineer, QMS

Job Summary

To maintain and improve compliance of the Quality Management System, the full-time Quality Engineer, QMS will support regulatory compliance efforts, manage supplier qualifications, and oversee audit processes, with flexibility for remote work.

Key responsibilities

• Support the compliance of a 21 CFR Part 820 and ISO 13485 quality management system by drafting and reviewing procedures
• Conduct supplier qualification activities, including evaluations, audits, and addressing nonconformances
• Manage audit scheduling and results, ensuring timely completion of corrective actions and compliance documentation

Required qualifications

• Bachelor's degree in a relevant scientific/technical field or equivalent 5 years of experience in a regulated industry
• 5+ years of quality management experience in a regulated environment following ISO 13485:2016 and 21CFR Part 820
• Experience with electronic Quality Management Systems (eQMS)
• Certified Quality Auditor, Certified Quality Engineer, or Certified Software Quality Engineer is desired but not required
• Proven ability to work autonomously with strong analytical and problem-solving skills