Medical Device Quality Engineer - Brasseler (On-site Savannah, GA)
Core
Develop and implement quality 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
Required skills
Risk management, Design and process validation, Supplier quality management, Root cause analysis, CAPA implementation, Regulatory compliance (FDA, ISO 14971, IEC 60601), Statistical analysis, Computer system validation (via careerplan.io/jobs/R132663-medical-device-quality-engineer-brasseler-on-site-savannah-ga-at-henryschein)
Preferred skills
Lean and Six Sigma, ASQ Certification, MBA, Master's in Engineering
Technologies
None explicitly listed
Responsibilities
Engage in continuous improvement for product design and manufacturing processes; Drive supplier quality improvement and qualification; Conduct trend analysis and business impact analysis for corrective actions; Provide quality engineering insight for product development and validation; Plan and assure product/process quality including process planning and measurement systems; Author validation and inspection assessments; Maintain knowledge of global quality and regulatory standards.
Seniority
Mid-level, hands-on IC