Quality Engineer
Core
Ensures product, process, and quality system performance in a regulated medical device manufacturing environment through hands-on engineering and QMS ownership.
Role type
Quality Engineer (Medical Device Manufacturing)
Builds
Medical devices and components for stent crimping, catheter manufacturing, and thermal forming applications.
Domain
Medical device manufacturing / Quality Engineering
Required skills
Root cause analysis, CAPA management, document control, calibration program administration, supplier quality management, internal auditing, data analysis for defect trends, risk management, process controls
Preferred skills
ISO 13485, FDA QSR (21 CFR 820), ISO 14971, SPC, Cpk/Ppk analysis, MSA/Gauge R&R, PFMEA/DFMEA, process validation (IQ/OQ/PQ), QMS/ERP software, statistical software
Technologies
MasterControl, ETQ, M1, Infor LN, Minitab
Responsibilities
Administer document change control and master document lists; manage calibration programs and measurement system analysis; lead NCR, CAPA, and RCA investigations; support supplier qualification and SCARs; participate in internal and external audits; analyze defect and warranty data to drive improvements.
Seniority
Mid-level, hands-on IC