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
CompensationBase 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.
BenefitsAt RareCyte, we support our employees in and out of the office. Click
here to view a list of benefits offered to eligible employees.
We love talking to qualified candidates! Even if you don't fit the description perfectly, please still apply and we'll review your resume.
