Quality Engineer - Brasseler
Core
Developing and implementing systems to ensure medical device products and services meet regulatory requirements and customer expectations.
Role type
Quality Engineer (Medical Devices)
Builds
Medical instrumentation and devices
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, Design and manufacturing change management, CAPA investigations, Supplier quality analysis, Root cause analysis, Statistical process control, Computer system validation, Regulatory compliance (FDA, MDD/MDR, ISO14971)
Preferred skills
Lean and Six Sigma, ASQ Certification, MBA
Technologies
None explicitly listed beyond regulatory standards
Responsibilities
Engage in continuous improvement activities for product design and manufacturing processes; Drive supplier quality improvement and partner with manufacturing personnel; Conduct trend analysis and business impact analysis for corrective actions; Provide quality engineering insight on product development and validation; Plan and assure product and process quality per quality principles; Author validation and inspection assessments; Maintain knowledge of global quality and regulatory standards; Conduct computer system validation.
Seniority
Mid-level, hands-on IC