Quality Systems Specialist

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 Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS).This role supports quality system processes including document control, training, change control nonconformance, and CAPA activities. The specialist monitors quality metrics, assists with audits, and ensures compliance with applicable global regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820.

Essential Job Functions and Responsibilities

• Support monitoring and continuous improvement of Quality Management System processes.
• Collaborate with Engineering, Manufacturing, and Quality teams on the development and sustaining of quality processes.
• Support internal and external audit preparation and execution activities.
• Monitor and trend Quality Management System nonconformances and quality data for escalations.
• Drive training activities and tracking to ensure compliance with all applicable regulations and key performance indicators.
• Assist with generation, analysis, and presentation of quality metrics.
• Support the Corrective and Preventive Action (CAPA) program, including coaching CAPA owners, drive comprehensive and audit-ready investigations and effectiveness checks.
• Support document control activities, including review, approval, and change management within the electronic QMS.
• Track and assess new or revised external standards and regulatory requirements ensuring that involved processes are maintained for continued compliance.
• Ensure adherence to company procedures and applicable regulatory and quality standards.
• Maintain effective working relationships with internal and external stakeholders.
• Support additional quality system activities as assigned.

Required Qualifications

• Bachelor’s degree in engineering, medical, science, or equivalent experience. . Previous experience in the role can be considered.
• Minimum of 3 years of experience supporting quality systems within a regulated environment.
• Prior experience in the medical device field is required; preferably experience with disposable and capital equipment medical devices. 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.
• Fluent in English (written and verbal).

Desired Qualifications

• Strong interpersonal skills and ability to work cross-functionally.
• Self-motivated with strong organizational skills.
• Strong written and verbal communication skills.
• Lead Auditor Certification preferred.
• Certification or training in Lean Six Sigma is a plus.

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.