Sr. Associate Quality Assurance Engineering
Core
Develop, modify, and maintain quality evaluation and control systems; devise inspection methods; manage product quality risks for medical devices and equipment.
Role type
Senior Associate Quality Assurance Engineering (Science/Tech/Engineering Path)
Builds
Quality evaluation and control systems, inspection methods, and risk management protocols for medical products.
Domain
Medical devices / Regulatory compliance (ISO 13485, ISO 14971, GxP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Root cause analysis, Corrective and Preventive Actions (CAPA) management, Validation and verification, SOP adherence, Risk management, Technical documentation, Equipment testing, Process optimization
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and maintain quality evaluation and control systems/protocols; Design and analyze inspection and testing processes and equipment; Conduct quality assurance tests and perform statistical analysis; Undertake root cause analysis of incidents and ensure corrective measures meet reliability standards; Review and approve investigations and facilitate CAPAs at third-party suppliers; Apply ISO 13485 and ISO 14971 principles to ensure compliance and risk management.
Seniority
Senior, hands-on IC
