**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.
**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**
The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA's, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.
**Responsibilities**
**Core Job**:
- Environmental and microbiological testing, such as non-viable and viable particles counting.
- Cleanroom environment sustaining.
- Sterilization concepts and product release.
- Contractor´s management, such as external laboratories and sterilization sites.
**Supporting**:
- NPI's activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
- Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
- Analyzes and performs failure analysis to non-conforming products.
- Leads in the implementation of assurances, process controls, nonconformances and CAPA.
- Develops and prepares monthly quality trend analysis and reports.
- Leads, coaches, and mentors non-exempt and entry level exempt personnel.
- Interpersonal skills.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
**Requirements**:
- Bachelor's degree in engineering or technical field or equivalent experience is required.
- Minimum of 3-5 years of experience.
- Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
- Able to read and understand technical data.
- Competent using Microsoft Office suites.
- Statistical analysis software a plus.
- Effective analytical, technical, and problem-solving skills.
- Ability to multi-task and manage multiple assignments in a timely manner.
- Good communication and interpersonal skills.
- Advanced English.
- Strong analytical skills.
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**EQUAL EMPLOYMENT OPPORTUNITY STATEMENT**
Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.