Quality Assurance Engineer for Post Market Surveillance

hace 2 semanas

Mexicali, Baja California, México Intuitive A tiempo completo

Company Overview

At Intuitive, we are united by our mission: we believe that minimally invasive care is the healthcare that enhances lives. Through innovation and intelligent technology, we expand the potential of physicians to heal without limitations.

As pioneers and market leaders in robotic surgery, we strive to foster an inclusive and diverse team committed to making a difference. For over 25 years, we have collaborated with hospitals and care teams worldwide to tackle some of the most challenging healthcare issues and advance what is possible.

Intuitive has been built on the efforts of exceptional individuals from diverse backgrounds. We believe that great ideas can come from anywhere: we work to cultivate an inclusive culture based on diverse thoughts and mutual respect. We lead with inclusion and empower our team members to work in the best way and express their authentic selves.

Passionate individuals who want to make a difference drive our culture: our team members are grounded in integrity, possess a strong ability to learn, have the energy to get things done, and bring diverse real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so that we can continue to advance our mission and reach their full potential.

Position Overview

The Post Market team at Intuitive operates at the crossroads of Regulatory and Quality. This team collaborates across the organization to gain a deep understanding of how our products and processes perform, the implications of any issues, and supports the execution of robust resolutions. Functions that work alongside the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering. The Post Market Team advocates for safety and effectiveness enhancements by evaluating field product performance and Quality Management System (QMS) processes to identify, investigate, communicate, and act on opportunities. The team requires a Quality Engineer with substantial hands-on experience in problem-solving, technical expertise with complex electro-mechanical devices, proficient technical writing skills, and a passion for best practices to analyze, monitor, and enhance both product and process.

Key Responsibilities

  • Reporting to the Senior Manager, Regulatory Post Market Surveillance, the Regulatory Post Market Surveillance Quality Engineer (RPMS QE) is accountable for managing Complaint Investigations; collaborating across the organization to identify and support continuous process and quality improvement initiatives that align with Intuitive standards and customer requirements while adhering to all applicable Medical Device Regulations and Standards.
  • Collaborate with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
  • Enhance existing processes and systems to ensure timely identification of product quality and compliance issues within a closed-loop quality management system.
  • The RPMS QE will collect and analyze data, drive thorough root cause analyses, and facilitate cross-functional discussions to ensure comprehensive resolution of issues.
  • Participate in internal and external audits as necessary, representing the Post Market Program.

Required Qualifications

  • Bachelor's degree in Engineering or a related field.
  • Minimum of 3 years of relevant experience in Quality, Engineering, Operations, or a continuous improvement environment.
  • Strong interpersonal and communication skills.
  • A commitment to enhancing products and processes.
  • Ability to assist others in finding innovative solutions within constraints.
  • Capable of delivering presentations to a diverse audience.
  • Experience in gathering and processing internal and external requirements.
  • Business acumen with demonstrated knowledge of the connection between projects and desired business outcomes.
  • Proven ability to investigate issues and drive creative problem-solving related to product and process issues, effectively documenting as necessary.
  • Ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment.
  • Technical aptitude to collect and analyze data for determining improvement strategies.
  • Ability to manage multiple projects with shifting priorities and execute to project timelines.
  • Willingness to travel up to 10% of the time.

Additional Information

Intuitive is an equal opportunity employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit any form of discrimination and harassment, regardless of race, sex, pregnancy status, sexual orientation, gender identity, national origin, color, age, religion, protected veteran status, disability, genetic information, or any other condition protected by applicable federal, state, or local laws.

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