Sr. Quality Engineer

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview  

The  Sr. Quality Engineer reports to the Quality Engineering Manager and is responsible for developing, implementing, maintaining, and supporting various quality engineering/improvement activities in a fast-paced and dynamic environment.  

Essential Job Functions

• Investigate causes of quality problems identified from field complaints, field service records, manufacturing, final QC inspection, incoming inspection, and suppliers.
• Manage the root cause analysis and corrective actions process of supplier quality issues.
• Support departmental effort in CAPA investigation and completion.
• Collect, analyze, trend, and communicate quality data throughout the organization.
• Identify validation and/or verification required for design changes.
• Support manufacturing, new product development, and regulatory to ensure compliance with all internal and external requirements; represent quality interests and concerns on project teams.
• Implement and qualify software tools related to product or process changes.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Carry out supplier qualification or surveillance audits, with supplier support and supplier advanced product quality planning. Write associated audit reports for distribution to senior management.
• Support new product launches and/or manufacturing transfers and/or sourcing projects to ensure suppliers can deliver to the required quality standards.

Requirements/Qualifications

• Bachelor’s degree in Electrical or Mechanical Engineering (or similar) required.
• Minimum of 4+ years of hands on experience with quality engineering manufacturing and field support.

• Prior experiences in a regulated environment, preferably medical device.
• Familiarity with use of mechanical and electrical test equipment.
• Basic statistical analysis skills and proficiency with MS Office.
• Ability to work effectively in a fast paced and dynamic environment.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
• Strong written and verbal communication skills.

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy Notice. 

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at peopleops@outsetmedical.com.

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.