Senior Quality Engineer San Diego, CA • Quality

Senior Quality Engineer

San Diego, CA
• Quality

• 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 and quality documentation.
• Strong organizational and communication skills, with the ability to manage multiple priorities, exercise sound judgment, and clearly communicate complex concepts.
• Highly methodical, detail-oriented, and comfortable operating in a fast-paced, evolving development environment.