Senior Quality Assurance Engineer
Core
Ensuring quality management and assurance processes for medical device manufacturing at a production site, supporting compliance with ISO13485 and FDA QMSR regulations.
Role type
Senior Quality Assurance Engineer (Medical Device Manufacturing)
Builds
Compliant manufacturing processes and quality management systems for medical device products
Domain
Medical device manufacturing / Regulated process industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO13485 compliance, FDA QMSR knowledge, GMP awareness, audit participation, non-conformance investigation, corrective and preventive action (CAPA) implementation, continuous improvement, cross-functional collaboration, statistical process analysis (SPC)
Preferred skills
Statistical process analysis, SPC
Technologies
ISO13485, FDA QMSR, GMP
Responsibilities
Develop and implement QMS according to FDA and ISO13485 standards, participate in audits, investigate non-conformances, implement CAPA, drive quality culture, cooperate with site departments and sister sites
Seniority
Senior, hands-on IC
