Advanced Quality Engineer
Core
Analyzes defects, manages non-conformances, and drives Corrective and Preventive Actions (CAPA) to optimize operational performance and elevate product quality benchmarks.
Role type
Senior IC quality engineer (manufacturing/process)
Builds
Manufacturing quality systems, process validation protocols, and continuous improvement initiatives
Domain
Healthcare technology manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis (RCA), CAPA Methodologies, Process Quality Management, Data Analysis & Interpretation, Regulatory Requirements, Manufacturing Processes, Process Monitoring, Technical Documentation, Process Engineering, Continuous Improvement
Preferred skills
Design for Quality (DFQ), Privacy, Safety and Security Risk Assessment
Responsibilities
Analyze defects and determine dispositions of non-conformances; Conduct impact assessments for Process Failure Mode and Effects Analysis (PFMEA) and assist in Manufacturing Process Development; Support operations performance monitoring, risk assessment, and supplier quality engineering; Coordinate quality engineering tasks and ensure manufacturing quality systems are maintained; Develop multi-disciplinary approaches to initiate process improvement activities; Apply advanced statistical analysis techniques to interpret complex data trends; Ensure execution of intricate process validation protocols; Prepare and deliver detailed quality metrics and reports to stakeholders; Participate in investigations and collaborate with suppliers, R&D, and manufacturing teams.
Seniority
Senior, hands-on IC
