What are the responsibilities and job description for the Quality Assurance Specialist position at Tasso?
Who We Are
Tasso is a fast-growing Seattle-based startup that delivers at-home diagnostic testing to those who need it most. We are growing our footprint with leading health systems, clinical research organizations, academic medical centers, and more who are looking to deliver clinical-grade, convenient diagnostic tests to their patients. Tasso was originally founded to find a better way to collect blood than a painful fingerstick or time-consuming venous draw. Since then, our products have been used in pharmaceutical clinical trials, by Olympians as part of a new virtual anti-doping program, and broadly by hospital systems across the US.
We are looking for a Quality Assurance Specialist responsible for Corrective and Preventive Actions who will provide CAPA support to the Quality team. This position will report to our Quality Manager.
What You Will Do
- Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations.
- Provides operational leadership to the CAPA organization and to multifunctional teams composed of technical subject matter experts involved in the resolution of quality issues and continuous improvement of the quality system.
- Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
- Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled in manner.
- Must be able to communicate the work and decision-making process of investigations to a professional staff of engineers and higher-level management.
- Provides subject matter expertise on the CAPA process during internal and external inspections.
- Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
- Position involves interactions across multiple functional areas including Manufacturing Engineering, Customer Service, Marketing, Supply Chain, Quality, and Regulatory.
- Accountable to the Quality Organization for achieving mutually agreed upon objectives.
- Compile and institute quality metrics to present at review meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.
- Perform other duties and projects as assigned.
Who You Are
- Experience in healthcare regulated industry (Med Device, IVD, biotech/Pharmaceutical)
- Bachelor's Degree in technical or life sciences and 5 years' experience in working in a regulated environment or equivalent combination of education and work experience.
- An ideal candidate will have a minimum of 5 years of experience in root cause analysis and process improvement in the medical device field.
- Working knowledge of investigational and Root Cause Analysis Techniques.
- Ability to apply strategic, quality logic and excellent project management skills to investigation activities.
- Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485.
- Able to independently determine and develop an approach to various issues and problems.
- Solutions must be thorough, practical, and consistent with organizational objectives.
- Must have strong organizational, interpersonal, written, and verbal communication skills.
- Must be self-directed, adept at juggling multiple projects, and comfortable in a fast-paced and ever-changing work environment.
- Must be proficient in MS Outlook, Word, and Excel and data reporting, trending, and analysis.
Compensation Package
$90,000/yr - $95,000/yr base Stock Options
We offer competitive compensation, benefits, and a fantastic work environment:
- 100% paid Medical, Dental & Vision for employees and generous subsidy for dependents
- 11 Paid Holidays and generous time off policies
- 401K Employer Match
- Paid parental leave policy
- Flexible hybrid work policy (In Seattle)
We have a strong healthcare-driven mission, and your guidance and efforts will directly link to our success. We embrace diversity and equal opportunity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be for it.
Salary : $90,000 - $95,000