quality engineer
Core
Lead investigations for nonconforming material, in-process failures, complaints, and field issues while supporting new product development and validation.
Role type
Senior quality engineer (medical devices)
Builds
Validated medical devices and compliant manufacturing processes
Domain
Medical devices / Quality Engineering
Required skills
root cause analysis, CAPA implementation, risk assessment (pFMEA), audit support, data analysis, regulatory knowledge, design transfer validation, stakeholder management
Preferred skills
medical device regulations, quality management standards, risk management standards, internal/external process knowledge
Technologies
pFMEA, CAPA, quality statistics
Responsibilities
Lead investigations for nonconforming material, in-process failures, complaints, and field issues; Support new product development and validation; Perform risk assessments; Develop and implement CAPA; Ensure purchased components meet specifications; Participate in internal and external audits; Analyze quality data and trends to drive continuous improvement
Seniority
Senior, hands-on IC