Quality Complaint Analyst

Outset Medical, Inc.; Tijuana; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. is seeking a Complaint Handling Specialist to execute and maintain the complaint lifecycle across the Tablo Hemodialysis System program.

You will work with Customer Support, Engineering, Service, and Medical/Clinical advisors to ensure accurate documentation, timely investigations, and compliant reportability. The role requires a Biomedical Engineering or related degree, 2+ years in medical devices, and strong knowledge of FDA QMSR/ISO 13485.

Formación

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field.
• Minimum 2 years in the medical device industry, preferably QA, Complaint Handling, or PMS.
• Working knowledge of FDA QMSR, ISO 13485, and U.S. regulatory requirements.
• Familiarity with FDA MDR (21 CFR Part 803) and complaint handling processes.

Responsabilidades

• Contribute to continuous improvements of the Complaint Handling process.
• Provide information for timely Adverse Event reporting.
• Manage complaints through lifecycle with cross-functional teams.
• Assist with investigations, root cause analysis, and CAPA as needed.
• Ensure documentation and timely closure per procedures and regulations.

Conocimientos

Analytical skills

Problem solving

Attention to detail

Quality Assurance

FDA QMSR

CAPA

Documentation

MS Office

eQMS

Educación

Biomedical Engineering degree

Herramientas

Microsoft Office

eQMS

Descripción del empleo

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.

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 [e-mail] .

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.