Quality Engineer, QMS

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