Senior Quality Engineer
Core
Provide Quality Engineering support for quality assurance, quality control, and continuous improvement across manufacturing operations, products, and processes in the peripheral vascular division.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Manufacturing operations, products, and processes
Domain
Medical Devices / Peripheral Vascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk management, CAPA, auditing, statistical methodologies, supplier quality management, measurement system analysis (MSA), test method validation, compliance risk assessment
Preferred skills
CQE or CRE certification, Six Sigma Green or Black belt, FDA/regulatory inspection experience, automated inspection programming
Technologies
Microsoft Office, Gage R&R
Responsibilities
Partner with operations and suppliers to drive product and process quality performance; Own and support nonconformances, CAPAs, and MRB activities; Monitor and report quality metrics using statistical methods; Support manufacturing complaints and containment activities; Develop and improve quality system documentation and inspection methods; Participate in internal and external audits.
Seniority
Senior, hands-on IC
