Quality Assurance Engineer (Onsite)
Core
Provide quality engineering support in quality assurance, control, and preventative activities to ensure product and process quality meets standards and specifications.
Role type
Quality Assurance Engineer
Builds
Ensures compliance to regulations and standards for medical device products and processes
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analyze quality data, maintain KPIs, review nonconformance records, conduct risk assessments, support validation activities, partner on customer complaint investigations
Preferred skills
Risk management, corrective and preventive actions, statistical analysis, medical device regulations (ISO 13485, GMP), audit support, regulatory agency interaction
Technologies
Standard computer applications
Responsibilities
Collaborate with cross-functional teams to ensure product and process quality; Review and approve nonconformance and corrective/preventive action records; Analyze quality data and maintain KPIs to monitor trends and reduce defects; Support change management processes by evaluating quality impact; Participate in internal and external audits; Conduct risk assessments and support validation activities; Partner with engineering and commercial teams to investigate customer complaints
Seniority
Individual Contributor