Senior Quality Engineer
Overview:
In this role you support the quality framework for medical devices by ensuring investigations and regulatory-compliant processes. You will handle complaint reviews, SOP updates, and lab activities aligned with regulatory standards. You will apply analytical methods and support audits, contributing to the lab's quality objectives. This telecommuting position enables you to impact patient safety while collaborating with the global quality team at embecta.
Responsibilities:
- Lead and ensure compliance of product complaint investigations with FDA QSR, ISO 13485, and related directives
- Review and validate customer complaints for proper processing and investigation per corporate procedures
- Update and enforce SOPs, equipment maintenance, hazmat and biohazard disposal protocols for the lab
- Perform FTIR analysis and other qualitative/quantitative analyses to identify materials and investigate foreign matter
- Program mechanical lab equipment (e.g., Chatillon) and analyze generated data
- Provide audit support, including preparation and facilitation of lab tours
- Support CAPA processes and engineering design change management for medical devices
Key requirements:
- Master's degree in Engineering (any) with 3 years of relevant experience, or Bachelor's degree with 5 years of relevant experience
- Experience with regulatory and international standards including 21 CFR 820, ISO 13485, ISO 14971 Statistics for trend analysis and complaint data evaluation
- Proficiency in Quality Engineering tools: Root Cause Analysis, Design of Experiments, Statistical Analysis
- Experience with internal and external quality audits and QMS representation during external auditsCAPA investigation, root cause analysis, and corrective actions
- Engineering Design Change Management and DHF management for medical devices
- Analytical thinking
Detail-oriented
Collaborative cross-functional communicationFTIR analysis
Quality systems regulation (FDA QSR)
Statistical analysis