Supervisor, Quality Operations

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 Supervisor, Quality Operations plays a critical role in ensuring compliance and quality assurance for medical devices in a highly regulated environment, adhering to ISO 13485 and 21 CFR Part 820 standards. This role supervises incoming inspection and calibration processes, manages emerging field feedback, and oversees quality communications for customer notifications. Serving as the quality representative for service and fleet management, the Supervisor supports the lifecycle of medical devices, field upgrades, audits, and inspections. This role leads a calibration technician and an incoming inspector, ensuring effective execution of quality processes in alignment with regulatory and company requirements.

• Essential Job Functions and Responsibilities:
• Incoming Inspection Managemen
• Calibration Process Oversight
• Emerging Field Feedback Management
• Customer Communications
• Fleet Management and Device End-of-Life Support
• Field Upgrades and Consignee Tracking
• Quality Management System (QMS) Support

Required Qualifications:

• Bachelor’s degree in engineering, quality, or a related technical field.
• Minimum of 3 years of experience in quality engineering or related roles within the medical device industry. Experience in service and support quality engineering preferred. 2+ years in a supervisory capacity preferred.
• Strong understanding of ISO 13485, 21 CFR Part 820, and related regulatory requirements for medical devices.
• Experience with non-conformance management, CAPA systems, and recall processes in a regulated environment.
• Excellent problem-solving skills with a focus on root cause analysis and corrective action implementation.
• Strong communication skills, with the ability to write clear, concise customer notifications and technical memos.
• Proficiency in managing device traceability systems and field actions.
• Ability to work cross-functionally and collaborate effectively with engineering, service, and regulatory teams.
• Self-motivated individual with a strong attention to detail and ability to manage multiple projects simultaneously.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Leadership and interpersonal skills to develop and manage good working relationships with direct reports and peers.

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.