As a Quality Engineer 2 within the Global Operations Group, you will ensure manufacturing processes and products meet rigorous quality standards by designing, implementing, and maintaining quality assurance within the quality management systems. You will be responsible for developing methods to inspect, test, and evaluate production accuracy while analyzing data to identify trends and resolve technical challenges. Your daily work involves investigating manufacturing issues, performing root cause analysis with cross-functional teams, and executing corrective actions. You will manage quality documentation, monitor metrics, and participate in process, product, and line audits. The role requires expertise in statistical analysis, Lean Manufacturing, Six Sigma, and ISO 9001 systems. You will utilize tools like Power BI and Minitab to support continuous improvement initiatives within a high-tech manufacturing environment to ensure reliable product delivery.
QMS
CAPA
ISO 13485
FDA QSR
Six Sigma
Lean
DMAIC
Minitab
Python
VBA
Root Cause Analysis
FMEA
MES
Data Analytics
Statistical Analysis
Validation
Risk Management
ISO 13485
FDA Quality System
CAPA
Root Cause Analysis
Risk Management
Process Validation
Six Sigma
Change Control
Nonconforming Product Control
Quality Engineering
Product Reliability
Continuous Improvement
Firmware Validation
Python
Bash
Swift
C
Objective-C
C++
Robotic Automation
LLM
AI
Hardware Debugging
Oscilloscopes
Logic Analyzers
Regression Testing
Test Automation
Algorithm Validation
Data Analysis