Process Quality Engineer
Core
Ensures high-quality performance and compliance in medical device factories by analyzing defects, managing non-conformances, and driving continuous quality improvement.
Role type
Process Quality Engineer (Medical Devices)
Builds
Manufacturing quality systems, process validation protocols, and corrective/preventive action plans.
Domain
Medical Devices / Manufacturing Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA implementation, PFMEA assessment, root cause analysis, statistical analysis, process validation, change management, supplier quality coordination, NPI support, regulatory compliance (ISO 13485), data analytics for quality insights
Preferred skills
Advanced statistical analysis, transformative process enhancement, multi-disciplinary approach, stakeholder relationship building
Technologies
ISO 13485, PFMEA, CAPA, NPI, Quality Management Systems
Responsibilities
Analyze defects and manage non-conformances; assess impact of design changes on process controls; support operations performance monitoring and risk assessment; coordinate quality engineering tasks for NPI and product transfers; execute process validation protocols; prepare quality metrics and reports for stakeholders; collaborate with suppliers and R&D to resolve quality issues.
Seniority
Mid-level, hands-on IC
