Quality Engineer

hace 5 meses

Tijuana, México Outset Medical A tiempo completo

**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**

***The Quality Engineer will focus on manufacturing support, non-conformances records, failure investigation, tracking and reporting on monthly basis and compiling and presenting data for KPIs meeting, execution, and approvals of change orders, monitor process, component, or supplier issues.

**Essential Job Functions and Responsibilities**
- Production quality support as required.
- Support or execute engineering or document change orders for process improvements.
- Execute the non-conforming process and coordinate containment activities.
- Support on process validation execution. (TMV, IQ, OQ or PQ).
- Develop Quality Alerts for various customer, internal and supplier issues.
- Reviews and participates in the update process of FMEA's and risk assessment for medical devices.
- Analyzes and performs failure analysis (investigation) to non-conforming products to determine trends and recommend corrective actions.
- Support in internal/external Quality Audits.
- Collaborate with manufacturing, supplier, R&D engineers to establish the production processes and test methods in manufacturing process.
- Collaborate in the KPI's process.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
- Excellent interpersonal skills.
- Ability to communicate effectively with all levels of staff and management.
- Support additional activities, as assigned.

**Required Qualifications**
- Bachelor's degree in industrial, Mechanical Engineering or equivalent experience is required.
- A minimum of 3 year of quality experience in a medical device or other regulated industry is required.
- Understand of medical device regulations and standards such as _21 CFR 820, GMP, GDP, ISO 13485, and ISO 14971._
- Competent using Microsoft Office suites.
- Knowledge and understand technical data (drawings, GD&T, etc.)
- Knowledge of statistical analysis software (Minitab).
- Knowledge and comprehension of sampling plans (AQL, ANSI, C=0, etc.).
- Must be able to communicate fluently in both written and spoken English.
- Strong analytical and problem-solving skills.

**Desired Qualifications**
- Quality Assurance Certification.
- Knowledge of pFMEA.
- Lean six sigma principles.
- US Visa

**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 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. They do this in an environment that challenges, supports, and broadens mindsets.

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 ju

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