Senior Quality Engineer
Core
Ensuring business compliance with the Quality Management System and regulations for clinical diagnostic instruments.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Compliant manufacturing processes and quality records for diagnostic instruments
Domain
Life sciences, diagnostics, biotechnology
Required skills
Engineering degree (Mechanical, Electrical, Chemical), Design Controls (21CFR820), Risk Management (ISO14971), SOP review, CAPA management, Lean process improvement, Defect reduction, Nonconformance analysis, Risk assessment
Preferred skills
Certified Quality Engineering certification
Technologies
21CFR820, ISO14971
Responsibilities
Conduct comprehensive reviews of manufacturing SOPs, document change orders, and quality records for regulatory compliance; Lead Kaizen events to improve transactional processes and implement lean production methods; Reduce instrument defects and nonconformances by implementing countermeasures; Assess risks associated with design changes, internal non-conformances, post-launch issues, and systemic quality system issues
Seniority
Senior, hands-on IC
