Senior Quality Assurance Engineer

We are seeking a Senior Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in quality management systems, regulatory standards, and manufacturing processes. They will design, implement, and maintain quality assurance protocols to ensure the delivery of high-quality products.

Requirements

• In-depth understanding of quality management systems (QMS) and regulatory standards (e.g., GMP, GLP, ISO, FDA, Six Sigma)
• Strong knowledge of manufacturing, sterilization, and cleanroom processes
• Familiarity with quality assurance methodologies such as Root Cause Analysis, Lean, Total Quality Management (TQM), and Statistical Process Control (SPC)
• Solid foundation in microbiology, molecular biology, biochemistry, chemistry, or related scientific disciplines
• Expertise in nucleic acid amplification, detection technologies, and the scientific method for data analysis
• Advanced technical writing and documentation skills to author quality assurance reports, procedures, and investigation protocols
• Excellent electrical failure troubleshooting
• Strong analytical skills for evaluating large datasets, identifying trends, and drawing valid scientific conclusions
• Proficient in quality improvement tools such as CAPA, HRA, HHE, MRB, and SCAR processes
• Excellent project management skills with the ability to plan, prioritize, and execute multiple projects within deadlines
• Proficiency with computer tools, including word processing, spreadsheets, and databases
• Strong interpersonal and collaboration skills to work effectively with cross-functional teams, mentor junior engineers, and present findings to stakeholders
• Working knowledge of FDA and ISO regulations governing medical devices is highly beneficial

Benefits

• Comprehensive training and development opportunities
• Annualized base salary range of $94,000-$146,900
• Bonus eligibility