Associate Quality Engineer

Job Summary

Supporting quality system processes in a remote capacity, the full-time Associate Quality Engineer will manage internal and external audits, assist with CAPA and nonconformance investigations, and contribute to quality compliance in CLIA laboratories and CE-IVD kits.

Key responsibilities

• Support internal and external audits (CLIA/CAP, ISO 13485, customer)
• Assist in CAPA, Deviation, Change Requests, and Nonconformance investigation and reporting
• Write and revise procedures and forms while ensuring compliance with quality systems

Required qualifications

• B.S. or equivalent in science, engineering, or related field
• At least 4 years of experience in the medical diagnostic, CLIA laboratory, or Life Sciences industry, with 2 years in a Quality role preferred
• Experience with internal, third-party, and/or regulatory audits
• American Society of Quality certifications (CQE) preferred
• Knowledge of CLIA/CAP regulations, ISO 13485 standard, and FDA QSRs (21 CFR 820)