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.

### 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

### Qualifications

8+ years of directly related experience; 1- 2 years in a lead role preferred
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 in a dual-function company with both manufacturing and clinical lab operations is highly desirable
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

### Compensation

Base Salary Range: $150,000 - $180,000 (annualized)

Determining a base wage will be based on several factors which include skill set, level of education, experience and qualifications, as well as the comparison to RareCyte internal equity. Some roles may also qualify for additional compensation such as bonus, commission, stock options and travel allowance.

### Benefits

At RareCyte, we support our employees in and out of the office. Click here to view a list of benefits offered to eligible employees.

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We love talking to qualified candidates! Even if you don't fit the description perfectly, please still apply and we'll review your resume.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to RareCyte Human Resources at [email protected].

RareCyte is committed to maintaining a safe and healthy workplace for all employees. If there are future COVID-19 or similar pandemic outbreaks, RareCyte will follow applicable recommendations or requirements from the Washington State Department of Health and other relevant public health authorities regarding vaccine implementation and workplace safety measures for all team members. Vaccination may become a condition of employment where required or deemed necessary to maintain a safe workplace. Employees or applicants who are unable to comply due to a qualifying medical condition, disability, or sincerely held religious belief may submit a request for a reasonable accommodation through Human Resources at [email protected].

Director of Quality

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