Company Overview
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.
Position Overview
Responsible for monitoring and managing Quality Compliance activities including CAPA, Field Action and data analytics. Monitors metrics and drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Ensure compliance with evolving applicable Global Requirements and Regulations such as the MDSAP and EUMDR. The incumbent for this position will support additional activities, as assigned.
Essential Job Functions and Responsibilities
Support the Corrective & Preventive Actions (CAPA) program through partnering and project management while ensuring delivery of valuable feedback, good documentation, thorough investigations and attaining target due dates
Collaborate with cross-functional team members on processes and proper documentation
Manage planning, execution, and reconciliation of field action activities
Support documentation and decision making for potential field action events
Support internal and external inspection and audit activities
Monitoring and trending of key performance indicators for Quality Systems
Support tracking, monitoring and assessment of new and revised external standards to ensure continued compliance.
Ensure business alignment with established company procedures and worldwide regulations and standards
The role requires awareness of new or revised regulations and/or guidelines.
Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
Support additional activities, as assigned
Required Qualifications
Minimum 10 years supporting or leading efforts in a Quality function
Bachelor’s degree or equivalent experience (additional 4 years)
Previous medical device experience
Strong knowledge of Quality System requirements
Ability to work effectively in a fast paced and dynamic environment
Desired Qualifications
Lead auditor certificate and/or other Quality related certifications
Strong technical writing skills
Basic understanding of electronics, mechanics and/or medical device software
The Annual Salary Range for this role will be: $$96,714.70 - $130,849.00 *
We feel passionately about pay equality. Discretionary adjustments to the position’s starting compensation may be made in consideration of other relevant factors pertaining to eligible applicants, including, but not limited to, their specific skills, level, geographical location, and comparison to other employees already in the same or similar roles.
*This range represents our good-faith and reasonable estimate regarding what we reasonably expect to pay for this position at the time of posting.
Outset also offers the following benefits:
- Medical
- Dental
- Vision
- EAP/Mental Health
- Life Insurance/AD&D
- Short/Long Term Disability
- FSA (Dependent & Healthcare)
- HSA w/ Employer contribution
- Commuter Benefits
- 401K w/ company match
- ESPP
- Fertility benefits
- Wellness initiatives
- Legal Assistance
- Pet insurance
- Financial Advisement & Wellbeing
- Tuition Reimbursement
- Student Loan Payback
- Employee discounts
- Professional Development/Learning
- Collaboration Days (lunch onsite)
- Happy Hours/Karaoke
- PTO/Sick time
- Holidays + Volunteer Day
