Senior Quality Engineer
Core
Partner with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality, reduce risk, and advance operational excellence in a medical device and biopharmaceutical manufacturing environment.
Role type
Senior Quality Engineer (Manufacturing)
Builds
High-reliability medical devices and biopharmaceutical products
Domain
Medical device manufacturing / Biopharmaceutical manufacturing
Required skills
Root Cause Corrective Action (RCCA) investigation, Corrective and Preventive Action (CAPA) management, Material Review Board (MRB) disposition, supplier quality management, supplier audit execution, defect reduction strategies, engineering drawing interpretation
Preferred skills
ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, AS9100/ISO 13485/ISO 9001 regulatory knowledge, APQP/PPAP/FMEA/SPC methodologies
Technologies
8D, 5-Why, Fishbone, SCARs, Control Plans
Responsibilities
Lead RCCA investigations using 8D, 5-Why, and Fishbone methodologies; Facilitate and manage CAPA activities; Support Material Review Board (MRB) activities; Manage supplier quality performance and audits; Implement preventive actions to reduce defects and scrap; Support internal, customer, and third-party audits; Train and mentor team members
Seniority
Senior, hands-on IC