Quality Engineer
Core
Overseeing quality assurance processes, validations, and documentation to ensure compliance with industry standards and regulatory requirements in manufacturing operations.
Role type
Quality Engineer
Builds
High-quality manufacturing products and compliant processes
Domain
Manufacturing / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance protocols development, Regulatory compliance (ISO 9001, 13485, 14001), Process improvement methodologies (Six Sigma, Lean, Kaizen), Root cause analysis (5 Whys, Fishbone, FMEA), CAPA implementation, Internal/External audit management, SOP development, Data analysis for process metrics
Preferred skills
ASQ Certified Quality Engineer certification, Equipment validation expertise
Technologies
ISO 9001, ISO 13485, ISO 14001, Six Sigma, Lean Manufacturing, Kaizen, FMEA, 5 Whys, Fishbone Diagram
Responsibilities
Develop and maintain quality assurance protocols aligned with regulatory requirements; Conduct regular reviews of quality metrics and performance indicators; Lead continuous improvement initiatives to enhance operational efficiency; Conduct internal audits of quality processes and calibration records; Lead investigations into quality issues using root cause analysis techniques; Maintain accurate records of validation activities and audit findings
Seniority
Mid-level, hands-on IC
