Quality Assurance Specialist

hace 2 meses

Mexicali, Baja California, México Intuitive A tiempo completo

About Intuitive

At Intuitive, we're united behind our mission: we believe that minimally invasive care is care that improves lives. Through innovation and intelligent technology, we're expanding the potential of surgeons to heal without limits.

Our Culture

We're pioneers and leaders in robotic surgery, and we're committed to fostering an inclusive and diverse team that's dedicated to making a difference. For over 25 years, we've worked with hospitals and healthcare teams around the world to help solve some of the toughest challenges in healthcare and push the boundaries of what's possible.

Our Values

We believe that great ideas can come from anywhere: we strive to create a culture that's inclusive, based on diverse perspectives, and built on mutual respect. We lead with inclusion and train our team members to work together effectively and bring their authentic selves to work.

Our Team

We're driven by passionate people who want to make a difference: our team members are guided by integrity, have a strong ability to learn, the energy to get things done, and diverse real-world experiences that help us think differently. We actively invest in our team members to support their long-term growth and help us continue to advance our mission and reach our full potential.

Job Description

Essential Job Duties:

Initial roles and responsibilities for this position will include the following:

  • Quality Advocacy and Project Management.
  • Develop and apply corporate-level quality metrics.
  • Lead and project manage quality initiatives in one or more of the following focus areas: Product Quality, Data Quality, Process Quality.
  • Production facility validation planning, execution, and management for buildings, products, and processes located in Mexicali, Mexico.
  • Product Development: Handle projects of various product and subsystem types (System, Instruments, Vision, new products, product improvements, etc.). Plan and direct the creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Mexicali and OEM suppliers, utilizing clinical and engineering process compliance through the design and development of comprehensive procedures, including work instructions, flowcharts, forms, templates, checklists, and other product or process-related documentation, for recording, evaluating, and reporting quality data. Develop and implement methods and procedures for the disposition of discrepant material. Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
  • Failure Analysis: Provide quality expertise post-market release to the quality engineering support team to analyze returned products. Perform deep technical failure analysis based on the physics of failure.
  • Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical/operating room environment.

Qualifications

Required Skills, Experience, Education, and Training:

Competency Requirements: To adequately perform the responsibilities of this position, the individual must possess:

  • Requires a minimum of 5 years of related experience with a university degree; or 3 years' experience and a Master's degree; or a PhD; or equivalent experience.
  • Minimum 4+ years of working experience in Quality Engineering, or in a manufacturing environment, minimum 2 years in a medical device design or manufacturing environment.
  • Understanding of Quality and Compliance Systems.
  • Understanding of CFR 21 820/ISO 13485 requirements for making process or design changes.
  • Good grasp of quality control and tools.
  • Able to learn the product and process quickly and assess the impact of defects on the product.
  • Understanding of root cause investigation processes and able to initiate routine problem-solving investigations.
  • Involved in design and process improvement projects in the past.
  • Able to review qualification and validation protocols.
  • Understanding of manufacturing metrics.
  • Understanding of basic Excel data analysis operations (Pareto charts, and trends).
  • Able to work in various project teams as the Quality SME.
  • Able to communicate work tasks to various project team members.
  • Capable of compiling data in a format appropriate for presentation.

Preferred Skills and Experience

  • Able to cope with changes and uncertainties, and handle associate risks comfortably.
  • Able to ask questions and not stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
  • Brings unpleasant facts to discussion, does not hold back information.
  • Driven by results. Fully supports team decisions, even if they disagree with the decision.
  • Listens and respects others. Demonstrates constructive work relationships with others in the organization.
  • Sets priorities and manages time wisely, capable of identifying critical issues from trivial issues. Sets individual goals aligning with the team goal.

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