Senior Quality Assurance Engineer
Core
Design, implement, and monitor quality control programs for regulated volume manufacturing to ensure products meet specifications and regulatory compliance.
Role type
Senior Quality Assurance Engineer (Manufacturing)
Builds
Quality Management Systems (QMS), Quality Agreements, Quality Plans, and Risk Assessments for manufacturing operations.
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Systems, Manufacturing Quality, Risk Management, Requirements Management, Process Validation, Data Analytics, Statistical Methodologies, Regulatory Compliance (FDA/GMP/ISO), AI-enabled Quality Systems, Automated Decision-Support Tools, Predictive Quality Monitoring, Intelligent Process Optimization
Preferred skills
Medical Device Industry Experience, Quality System Expertise, Manufacturing Quality, Process Validation, Risk Management
Technologies
FDA Quality System Regulations, GMP, ISO standards, AI-enabled quality systems, automated decision-support tools, data analytics platforms
Responsibilities
Lead new product introduction into manufacturing; proactively improve quality systems and standardization across manufacturing units; perform or support internal, external, and supplier audits; develop Quality Agreements and Project Based Risk Assessments; utilize advanced data analytics and machine learning for root cause investigations and CAPA reviews; drive continuous improvement initiatives for automation and predictive monitoring; ensure compliance with FDA, GMP, and ISO standards; mentor and coach team members.
Seniority
Senior, hands-on IC with leadership responsibilities
