Quality Engineer III (Seismiq)
Core
Ensures product quality and process compliance in a regulated medical device manufacturing environment by investigating defects, managing non-conforming material, and leading validation activities.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Validated medical device products and compliant manufacturing processes
Domain
Medical Devices / Manufacturing / Quality Assurance
Required skills
Root Cause Analysis (RCA), Statistical Analysis, Validation Lifecycle Management, Risk Management (BSEN 14971), CAPA/NCEP/Failure Mode Investigation, ISO 13485/QMSR compliance, Six Sigma, Lean methodologies, Customer Complaint Investigation
Preferred skills
Experience with GCS2 software, Equipment evaluation and transfer, Internal auditing, Supplier and cross-functional collaboration
Technologies
Excel, Minitab, GCS2
Responsibilities
Identify and resolve complex exceptions to work assignments; Summarize, analyze, and make decisions from test results; Identify manufacturing process defects and disposition non-conforming material; Participate in customer complaint investigations; Review and develop process validation protocols and reports; Evaluate new equipment and processes for environmental impact; Compile and analyze operational data to establish technical specifications; Provide technical guidance to associate quality staff.
Seniority
Senior, hands-on IC