Senior Quality Assurance Engineer

hace 7 días

Tijuana, Baja California, México Outset Medical A tiempo completo

Company Overview

Outset Medical is a pioneering medical device company that is revolutionizing the field of dialysis. Our focus is to create a high-performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is to pioneer groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve better now, not someday.

At Outset Medical, we're impacting what the future of dialysis looks like by creating a first-of-its-kind technology to reduce the cost and complexity of dialysis. Our technology, the Tablo Hemodialysis System, is FDA cleared for use across care settings, from the hospital to the clinic to the home. 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

The Senior Quality Assurance Engineer plays a critical role in maintaining and enhancing the quality of supplies procured by the business. They oversee supplier performance, providing regular reports to management to ensure transparency and accountability. Additionally, they contribute to the refinement of supplier control plans, aiming for continuous improvement in quality standards. By collaborating with suppliers, the Quality Assurance Engineer helps develop and implement strategies to elevate the quality of purchased products across the board.

Responsibilities

  • Develop a Supplier Improvement Plan.
  • Ensure Supplier Audit Schedule Compliance.
  • Perform Supplier Trend Analysis to develop strategy.
  • Follow Up Corrective Actions, ensuring the implementation of corrective actions in response to quality issues, while also assessing the adequacy of root cause analysis tools employed to address reported issues.
  • Support or execute change orders for process improvements and determine when process stability and capability studies should be performed on existing suppliers.
  • Analyze and perform failure analysis to non-conforming products.
  • Review and participate in the Component Qualifications (PPAP), MSA and supplier Control Plans.
  • Provide input to supplier's scorecards.
  • Manage qualifications of changes, overseeing the qualification process for changes initiated by suppliers and the company, and coordinating associated change control activities to ensure seamless integration and compliance with quality standards.
  • Develop and prepare monthly suppliers quality trend analysis and reports.
  • Team Member in Supplier Qualification and Maintenance process, including audits.

Required Qualifications

  • Bachelor's degree in engineering or technical field.
  • Minimum of 7+ years of supplier quality or working with supplier qualification projects experience in a medical device or other regulated industry is required.
  • Strong verbal and written communication skills in English is required.
  • Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
  • Able to read and understand technical data (drawings, GD&T, etc).
  • Lead Auditor certification a plus.
  • Lean Certification a plus.
  • Competent using Microsoft Office suites.
  • Experience with statistical analysis software.
  • Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology.
  • Ability to multi-task and manage multiple assignments in a timely manner.
  • Good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation and customer satisfaction.
  • Strong analytical skills.

Company Culture

At Outset Medical, 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 Medical, 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 Medical's history, jam-packed interactive sessions with executive leadership, and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry. In SPARK, people managers across functions come together to master three pivotal conversations: 1) the priority conversation, 2) the performance conversation, and 3) the growth conversation.

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