Principal Post Market Quality Engineer

The Principal Post Market Quality Engineer serves as the senior technical authority for Post Market Quality Assurance, leading integrated, compliant, and risk-based post-market processes across Breast & Skeletal Health Solutions product lines to ensure patient safety, regulatory compliance, and continuous quality system improvement.

Knowledge

• Expert understanding of Post Market Quality Assurance processes across complaint handling, complaint investigation, medical device reporting, reportability, health risk assessment, and post-market data analysis/trending. • Deep knowledge of medical device regulations and quality system requirements, including: • 21 CFR Part 820 / QMSR • 21 CFR Part 803 • 21 CFR Part 806 • 21 CFR Parts 1000–1050 • ISO 13485 • ISO 14971 • EU MDR vigilance requirements • MDSAP • Strong understanding of FDA, Notified Body, and MDSAP inspection expectations. • Knowledge of risk management, health risk assessment, Health Hazard Evaluation, patient impact assessment, and risk acceptability. • Knowledge of how Post Market processes interact with design, manufacturing, CAPA, nonconformance, field actions, and overall quality system remediation. • Understanding of statistical methods, trending, signal detection, and emerging-risk evaluation. • Awareness of evolving global regulations, guidance, and industry practices. • Preferred knowledge of Salesforce-based complaint systems, Agile or other electronic QMS systems, test method validation, design of…