Director of Quality

RareCyte • Seattle, WA

3d • $150,000 - $180,000 • Hybrid

About The Position

RareCyte is a Life Sciences Precision Biology company focused on the development of novel technology and products in spatial biology and liquid biopsy. Our platforms have been adopted by leading research institutions and pharmaceutical companies worldwide for translational research, drug discovery and clinical programs. The breakthrough Orion technology is revolutionary in the spatial biology market, enabling tissue analysis with 20 channel whole-slide multiplex imaging in a single run. RareCyte is seeking a Director of Quality based in our Seattle, WA Headquarters. This position has the flexibility to work a hybrid schedule with 3 days in the office per week. This individual will be responsible for all Quality Assurance and Quality Control activities. A successful candidate will help refine, implement, and manage a quality management system compliant with 21 CFR 820, ISO 13485:2016, 42 CFR 493, ICH E6, and GDPR while promoting a culture of quality, compliance and continuous improvement throughout the organization.

Requirements

• 8+ years of directly related experience
• 4+ years of experience in a clinical laboratory, medical device manufacturing or development environment
• Bachelor’s degree (in biological sciences, chemistry, engineering or physics preferred) or equivalent experience
• Experience using and managing electronic quality management software, Q-Pulse Ideagen Quality Management a plus
• Strong computer skills, proficient with Microsoft Office suite
• Exceptional attention to detail with strong troubleshooting skills
• Audit experience to quality management system standards, ISO 13485:2016 preferred

Nice To Haves

• 1- 2 years in a lead role preferred
• Experience in a dual-function company with both manufacturing and clinical lab operations is highly desirable

Responsibilities

• Assures the quality of products and lab services by establishing and maintaining quality standards
• Works collaboratively with both internal and external clients/collaborators and with regulatory agencies to anticipate and resolve quality issues including filed alerts, recalls or regulatory actions
• Manages internal and external audits and ensures timely resolution of findings
• Supports validation and improvement projects and new product development
• Oversees supplier qualification and annual evaluations
• Leads Material Review Board (MRB)
• Ensures appropriate CAPA (Corrective and Preventive Actions) processes are in place and effective including supporting investigations associated with complaints, deviations and non-conformances
• Reviews and maintain all quality-related documentation and records including but not limited to SOPs, CAPAs, protocols, reports, document changes, master batch records, drawings, etc.
• Establishes standards for the disposition of finished product by devising evaluation tests, methods and procedures
• Administration of the electronic quality management system
• Leads Management Reviews; track and trend quality metrics
• Completes special projects and assignments as requested
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies

Benefits

• bonus
• commission
• stock options
• travel allowance

What This Job Offers

• Job Type: Full-time
• Career Level: Director