Senior Quality Assurance Engineer I
Core
Conducts complex quality engineering work for specific medical device product lines, focusing on failure investigation, risk analysis, supplier quality, and validation protocols.
Role type
Senior IC quality assurance engineer (medical devices)
Builds
Medical device product lines
Domain
Medical devices / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
failure investigation, risk analysis, supplier quality audits, validation protocol generation, nonconformance disposition, quality system optimization, statistical methodologies, regulatory knowledge (21 CFR 820, ISO 13485)
Preferred skills
MasterControl, SmartCAPA, Oracle, Crystal, deviation handling, CAPA management
Technologies
MasterControl, SmartCAPA, Oracle, Crystal
Responsibilities
Conduct failure investigations and determine disposition of nonconforming materials; coordinate risk analysis and management activities; review and generate Engineering Change Notifications (ECNs) for verification and validation methods; mentor and evaluate competency of Quality Auditors and Engineers; evaluate and select suppliers through performance monitoring and audits; ensure containment of nonconforming product; participate in design and development activities; support Internal and supplier audit activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
