Position: Quality Consultant
About: We are looking for a Quality Consultant to support our biotechnology operations by ensuring compliance with industry regulations and driving continuous improvement in quality management systems. This role involves collaborating with cross-functional teams to assess, enhance, and maintain quality standards across various processes.
Requirements: High school diploma or equivalent required; extensive experience in quality assurance, regulatory compliance, or risk management within the biotech, pharmaceutical, or life sciences industry; strong working knowledge of ISO 9001, ISO 13485 (for medical devices), ISO 17025 (for laboratory testing), and ISO 14971 (risk management for medical devices); ability to interpret and apply regulatory guidelines, including FDA 21 CFR Part 820, ICH Q10, and EU MDR; excellent analytical, problem-solving, and project management skills; actionable insights to executive leadership and operational teams
Benefits: health insurance, 401(k), flexible work schedule, employee discounts on food and beverages, comprehensive training programs
