Quality Engineer
Core
Managing and investigating customer complaints for oligonucleotide products to ensure compliant, timely, and effective resolution processes.
Role type
Quality Engineer (Complaints & Post-Market Surveillance)
Builds
Product quality improvements and regulatory compliance support
Domain
Life sciences, diagnostics, and biotechnology
Required skills
Root cause investigation (5-Why, Fishbone, DMAIC), CAPA management, post-market surveillance, data analysis, regulatory compliance (ISO 13485, 21 CFR 820/803), cross-functional collaboration
Preferred skills
Medical device/pharma/IVD industry experience, Six Sigma Green/Black Belt, Certified Quality Engineer (CQE), advanced degree in scientific/engineering discipline
Technologies
ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 803, QSR
Responsibilities
Investigate customer complaints by reviewing manufacturing records and analytical data; Prepare investigation summaries and documentation for audits; Support post-market surveillance including complaint trending and regulatory reporting; Partner with Manufacturing, QC, Regulatory Affairs, and R&D for continuous improvement; Initiate and support CAPAs to improve product quality.
Seniority
Mid-level, hands-on IC