Advanced Engineer DQA
Core
Lead quality assurance and product development for medical devices, ensuring compliance with regulations and driving continuous improvement across the full product lifecycle.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Medical device products compliant with US and international regulations
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, Process control, Statistical quality tools, CAPA implementation, Supplier quality management, Design control, Risk management, Regulatory compliance (ISO 13485/9001), FMEA, Control plan, MSA, PPAP
Preferred skills
Master's degree in engineering, CQE or PMP certification, Medical device industry experience
Technologies
MS Office, Adobe tools
Responsibilities
Lead projects to define testing strategies and minimize product failures during new product introduction; Develop and implement standardized methods for process control and validation; Execute experimental testing and data analysis to drive data-driven decision-making; Collaborate with suppliers and stakeholders to resolve complaints and drive continuous improvement; Ensure compliance and final release risk acceptance for NCMR and Deviation processes; Manage supplier-initiated change requests and validate implementations; Establish compliant product documentation for regulatory submissions; Conduct quality reviews of design and development documentation; Coordinate product testing activities with internal and external laboratories.
Seniority
Senior, hands-on IC
