--- title: 'Quality Complaint Analyst at Outset Medical' canonical: 'https://feeny.ai/job/quality-complaint-analyst-outset-medical-tijuana-29fyvk5fddx7' type: 'job' last_seen: '2026-10-29' --- # Quality Complaint Analyst at Outset Medical - **Company:** Outset Medical - **Location:** Tijuana, Mexico - **Posted:** 2026-10-26 - **Last confirmed live:** 2026-10-29 - **Apply:** https://job-boards.greenhouse.io/outsetmedical/jobs/8906965002 ## Job description 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 Responsible for the execution and maintenance of the complaint handling process by actively managing product complaints throughout their full lifecycle, from intake through investigation and closure. This role works closely with cross-functional partners, including Customer Support, Engineering, Service, and Medical/Clinical advisors, to ensure accurate documentation, timely investigations, and appropriate reportability assessments in accordance with established procedures and regulatory requirements. Essential Job Functions and Responsibilities - Contribute continuous improvements to the Complaint Handling process. - Provides information for timely Adverse Event reporting. - Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint. - Collaborate with Customer Support, Engineering, and Service teams to support complaint activities. - Perform reportability determinations in conjunction with medical advisor as necessary. - Be part of the Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. - Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. - The role requires awareness of new or revised regulations and/or guidelines. - Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance. - Support additional Quality Systems activities, as requested. - Support additional activities, as assigned. Required Qualifications - Bachelor's degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field. - Minimum of 2 years of relevant experience in the medical device industry required, preferably in Quality Assurance, Complaint Handling, or Post-Market Surveillance. - Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable U.S. medical device regulatory requirements. - Familiarity with FDA Medical Device Reporting requirements (21 CFR Part 803) and medical device complaint handling processes. - Understanding of Good Manufacturing Practices (GMP), quality management systems, and documentation practices. - Familiarity with complaint investigations, root cause analysis, and Corrective and Preventive Actions (CAPA). - Strong analytical, problem-solving, and attention-to-detail skills. - Ability to manage multiple priorities and work effectively in a fast-paced, cross-functional environment. - Proficiency in Microsoft Office; experience with electronic Quality Management Systems (eQMS) is a plus. - Fluency in English, both written and verbal. Desired Qualifications . - Excellent interpersonal skills. - A self-starter, motivated and able to positively motivate others. 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.](https://www.outsetmedical.com/wp-content/uploads/Applicant-Privacy-Notice.pdf) 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. ## About Outset Medical ## Core Business - **Primary industry**: Medical Equipment Manufacturing / Dialysis Technology - **Target customers**: Hospitals, health systems, dialysis clinics (B2B, enterprise) - **Mission or purpose statement**: “To give people their lives back” – enabling patients to fit dialysis into their life instead of fitting their life around dialysis. ## Products & Services - **Tablo Hemodialysis System**: A first-of-its-kind dialysis system that integrates water purification and on-demand dialysate production, eliminating the need for a dedicated water room. It serves as a single enterprise solution for acute, chronic, and home dialysis. (Hardware + Software) - **Outset Connect**: A data and analytics platform with seamless EMR integration that improves care and operational efficiency across the enterprise. (SaaS/Data Analytics) - **Insource with Outset**: A program that helps hospitals insource acute dialysis, including training, support, and enterprise deployment of Tablo. (Service) ## Market Standing - **Valuation/Market Cap**: Not publicly available in recent sources (stock price ~$3.85 as of mid-2026; market cap not explicitly stated) - **Key Metric**: Annual Revenue of $119.5M (latest fiscal year) - **Notable Investors/Partners**: Warburg Pincus (early backer), CRG (led $45M debt financing), Mubadala Capital Ventures (led $132M Series D), SLR Capital Partners ($300M post-IPO debt). IPO in September 2020. - **Growth Signals**: Nearly 1,000 hospitals and health systems have insourced acute dialysis with Outset; employee headcount of 368 (+2% YoY); active job postings across sales, engineering, and clinical roles; presence in Mexico and Philippines. ## Competitive Advantages - **Integrated water purification and on-demand dialysate production** – no water room needed, reducing infrastructure costs. - **Single enterprise solution** covering acute, chronic, and home dialysis – simplifies procurement and training. - **Clinical evidence** showing lower infection rates, fewer code blues, shorter ICU stays, and improved patient outcomes. - **Automated EMR integration** and a proprietary data analytics platform (Outset Connect) for better care coordination. - **Nurse training in under 4 hours**, enabling rapid adoption. ## Strategic Focus - Driving widespread adoption of Tablo across the care continuum, with a strong push to insource acute dialysis in hospitals. - Expanding into home hemodialysis to offer patients more flexibility and autonomy. - Continuing to build clinical evidence and operational efficiencies to lower total cost of care for providers. ## Why Work Here - **Culture**: Emphasizes curiosity, ingenuity, and conviction – “changing one of the largest, most expensive, and stagnant areas of healthcare.” - **Remote/Hybrid Policy**: Mixed – many roles are on-site (San Jose, Tijuana, field service across US), but some positions (e.g., Regional Lead, Clinical Excellence) are listed as remote. - **Growth Opportunities**: The company actively promotes internal mobility and provides “incredible growth opportunities” for current employees. - **Engineering & Technical Roles**: Active hiring in software (Android, SDET), hardware engineering, quality, and manufacturing – particularly in Tijuana, Mexico. - **Hiring Process**: Transparent 5-step process (recruiter phone → hiring manager → peer/team → talent activity → final with dept. head). No upfront payments or software installs required. - **Employee Ratings**: 3.9/5 on LinkedIn (228 reviews), with culture and compensation rated 4.0/5. ## Sources 1. [outsetmedical.com – About Us](https://www.outsetmedical.com/about-us/) 2. [outsetmedical.com – Homepage](https://www.outsetmedical.com/) 3. [outsetmedical.com – Careers](https://www.outsetmedical.com/opportunities/) 4. [Greenhouse – Jobs at Outset Medical](https://job-boards.greenhouse.io/outsetmedical) 5. [LinkedIn – Outset Medical Company Page](https://www.linkedin.com/company/outset-medical) ## Other roles at Outset Medical - [Clinical Excellence Manager](https://feeny.ai/job/clinical-excellence-manager-outset-medical-louisiana-mississippi-refy0700119z) — Louisiana / Mississippi - [Junior Software Engineer](https://feeny.ai/job/junior-software-engineer-outset-medical-tijuana-ma0zbane529z) — Tijuana, Mexico - [Senior Consumables Engineer](https://feeny.ai/job/senior-consumables-engineer-outset-medical-tijuana-baja-california-05t92jjp0xhf) — Tijuana Baja California, Mexico - [Senior Accountant](https://feeny.ai/job/senior-accountant-outset-medical-tijuana-n8vb3y118865) — Tijuana, Mexico - [Market Director (West)](https://feeny.ai/job/market-director-west-outset-medical-westpac-y512yx2p0y9h) — Westpac - [Director of Strategic Accounts](https://feeny.ai/job/director-of-strategic-accounts-outset-medical-remote-4k3kgtrwqnx5) - [Director of Strategic Accounts](https://feeny.ai/job/director-of-strategic-accounts-outset-medical-remote-y4t2qchsnv26) - [Director of Strategic Accounts](https://feeny.ai/job/director-of-strategic-accounts-outset-medical-remote-qf897njrhbra) - [Field Service Engineer II (Burlington/Central NC)](https://feeny.ai/job/field-service-engineer-ii-burlington-central-nc-outset-medical-burlington-anpznft4ctkh) — Burlington/central, NC - [National Account Director](https://feeny.ai/job/national-account-director-outset-medical-remote-h8qf5ch5sqez)