Site Head, Quality

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 Site Head, Quality is a critical member of the senior leadership team at Outset Medical’s Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory standards. This role drives quality excellence in the production of Class II medical devices (hemodialysis systems and consumable cartridges), ensuring patient safety and scalability to meet growing market demand. 

 

The ideal candidate is a hands-on leader who thrives in a fast-paced manufacturing environment, working closely with the Plant Manager, Head of HR, and Manufacturing Lead to foster a culture of quality, compliance, and continuous improvement. They will mentor and coach a team of 12-15 quality professionals, including quality managers, engineers, technicians, and inspectors, while spearheading strategic initiatives to support scalable manufacturing and regulatory compliance. The role requires regular travel between manufacturing and shared services sites in Tijuana, occasional visits to headquarters in San Jose, CA, and supplier sites for quality oversight. 

 

Key Responsibilities: 

• Develop and execute quality strategies that align with Outset Medical’s growth objectives, ensuring scalable manufacturing processes while prioritizing patient safety and regulatory compliance. 

• Lead and mentor a team of 12-15 quality professionals, fostering hands-on collaboration, professional development, and a culture of accountability in daily operations. 

• Oversee all QA functions at the manufacturing site, including incoming inspection, in-process quality control, design transfer, non-conformance (NC) management, Material Review Board (MRB), and Corrective and Preventive Action (CAPA) processes. 

• Direct premarket quality activities, including risk management, verification and validation, and support for regulatory submissions, ensuring robust design transfer to manufacturing. 

• Manage post-market surveillance, including complaint trend analysis, root cause investigations, and continuous product improvements to enhance patient safety. 

• Lead supplier quality programs, driving compliance and performance to support scalable production and reliable supply chains. 

• Serve as the primary QA representative during regulatory inspections and audits, ensuring successful outcomes and effective communication with regulatory bodies (e.g., FDA, notified bodies). 

• Collaborate within the global Quality function and cross-functionally with Manufacturing, R&D (Hardware and Software), Regulatory Affairs, Supply Chain, and other departments to align quality objectives with operational and business goals. 

• Develop and monitor key performance indicators (KPIs) for quality activities, such as defect rates, inspection efficiency, CAPA resolution times, and supplier performance, reporting progress and risks to senior leadership. 

• Champion continuous improvement initiatives using Lean/Six Sigma methodologies to optimize manufacturing processes, enhance product quality, and support scalability. 

• Foster a culture of quality and compliance through training, communication, and active engagement with manufacturing teams, emphasizing patient safety as a core value. 

 

Qualifications: 

• Bachelor’s degree in Engineering, Science, or a related technical discipline; advanced degree (e.g., MS, MBA) preferred. 

• 10+ years of progressive quality leadership experience in the medical device industry, with at least 5 years in a manufacturing environment for Class II or Class III devices. 

• Deep expertise in FDA 21 CFR Part 820, ISO 13485, and related global regulatory standards, with a focus on patient safety and compliance. 

• Proven track record of leading and mentoring diverse QA teams, with a hands-on approach to coaching quality managers, engineers, technicians, and inspectors. 

• Strong knowledge of manufacturing quality processes, including incoming inspection, design transfer, NC/CAPA management, MRB operations, and scalable production systems. 

• Demonstrated experience leading regulatory audits and interacting with regulatory bodies (e.g., FDA, notified bodies). 

• Exceptional strategic thinking, problem-solving, and decision-making skills, with a focus on practical application in a high-growth manufacturing setting. 

• Excellent communication and interpersonal skills, with the ability to build cross-functional relationships and present complex quality data to executives and external stakeholders. 

 

Preferred Qualifications: 

• Professional certifications such as Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE). 

• Lean/Six Sigma Green or Black Belt certification with proven experience applying continuous improvement methodologies in a manufacturing environment. 

• Experience with hemodialysis systems or similar capital equipment and consumables. 

• Familiarity with scaling quality systems to support high-growth manufacturing operations. 

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.