Quality Engineer
Core
Managing and investigating customer complaints for oligonucleotide products to ensure compliant, timely, and effective resolution while driving product quality improvements.
Role type
Quality Engineer (Regulated Life Sciences)
Builds
Compliant product quality processes and regulatory reporting
Domain
Life sciences, diagnostics, biotechnology, in vitro diagnostics (IVD)
Deliverable
client delivery
Required skills
Root cause investigation (5-Why, Fishbone, DMAIC), CAPA management, post-market surveillance, regulatory compliance (ISO 13485, 21 CFR 820/803), data analysis, cross-functional collaboration
Preferred skills
Medical device/pharma/IVD industry experience, Six Sigma Green/Black Belt, Certified Quality Engineer (CQE), advanced degree in science/engineering
Technologies
Quality management systems, data analysis tools
Responsibilities
Investigate customer complaints by reviewing manufacturing records and analytical data; Prepare investigation summaries and documentation for audits; Support post-market surveillance 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