2 jobs found in San Diego, CA

Senior Quality Engineer San Diego, CA • Quality Qualifications:  BS Degree or higher in Mechanical, Electrical, Chemical, Biomedical Engineering or related technical discipline 5+ years experience in a regulated medical device development environment (i.e. 510(k), PMA)  Demonstrated working knowledge of medical device quality systems and regulations, including design controls (21 CFR 820.30), ISO 13485, and associated practices such as Risk Management (ISO 14971) and Design History Files (DHF). Proven ability to apply statistical and data-driven methods to support design verification, validation, and quality decision-making, including understanding of sample size rationale, variability, confidence, and acceptance criteria. Experience using statistical and analytical tools (e.g., Excel, JMP, Minitab, R) Highly proficient with Windows-based business applications, including effective use of Excel for data analysis and Word/PowerPoint for preparation of technical...

Quality Engineer El Cajon, CA, 92020   Quality Engineer El Cajon, CA, 92020 POSITION SUMMARY Establish, monitor and maintain quality requirements to ensure products meet customer expectations and comply with industry and regulatory requirements. Support internal and external auditing activities and contribute to continuous improvement of the company's nuclear quality assurance program (NQAP). ESSENTIAL DUTIES AND RESPONSIBILITIES Establish, monitor and maintain quality requirements to ensure products meet customer expectations and comply with industry and regulatory requirements. Prepare quality assurance program and verification plans in accordance with customer order requirements. Develop, plan and deploy activities in the application and maintenance of quality standards for manufacturing processes, materials, products and/or business systems. Establish and provide written procedures for quality assurance systems. Review and provide recommendations...