**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 monitoring and managing all areas of Complaint Handling activities. Monitors metrics and drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Initiate and facilitate corrective or preventive actions as needed. Ensure quality customer and regulatory communications for current products. Assist in ensuring compliance with evolving General Requirements and Regulations such as MDSAP and EUMDR. The incumbent for this position will support additional activities as assigned.
**Essential Job Functions and Responsibilities**




- Investigate reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.
- Contribute to continuous improvements to Complaint Handling process.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- 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.
- Provides information for timely Adverse Event reporting.
- Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
- Excellent interpersonal skills
- A self-starter, motivated and able to positively motivate others
- Focused, target driven with a positive, can-do attitude
- Support of additional Quality Systems activities, as requested.
**Required Qualifications**
- Bachelor's Degree in engineering or technical field or equivalent.
- 3+ year experience working in a regulated industry or similar manufacturing and engineering environments preferred.




- Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation.
**Desired Qualifications**
- Ability to understand priorities.
- Ability to work independently and address obstacles that may arise.
- Ability to work in fast paced and dynamic environment.
- Strong analytical skills.
- Excellent written and verbal communication skills.
- Fluent in English (both written and verbal)
- Accuracy is required in performing all functions of this position.
- Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat. Salesforce Experience 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.
And this doesn't happen by accident. It starts with our live onboarding program, Bold Beginnings, which serves as an incubator for cross-functional team-building, an immersion in Outset's history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It co

📌 Quality Complaint Analyst (Tijuana)
🏢 Outset Medical
📍 Tijuana