Supplier Quality Engineer - Tijuana, México - Outset Medical

Outset Medical

Empresa verificada

Tijuana, México

hace 1 semana

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Company Overview
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis.

The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers.

Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone.

The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.

Position Overview

You will be responsible for supporting the supplier quality engineering activities as new supplier qualification, components changes qualification, supplier audits, non-conformance investigation, internal audits support, additional to support manufacturing operations to manage any component quality issues concern.

You will advise the company management on quality assurance requirements and review non-conforming product along with product risk assessment and perform product failure investigations.

Finally, you'll drive Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.

Essential Job Functions

Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing suppliers.
Analyzes and performs failure analysis to nonconforming products.
Review and participates in the Component Qualifications (PPAP), MSA and supplier Control Plans
Leads in the implementation of assurances, process controls, nonconformances and SCAR ́s.
Provides input to supplier's scorecards.
Manage qualifications of changes and coordinates associated change control activities.
Develops and prepares monthly suppliers quality trend analysis and reports.
Team Member in Supplier Qualification and Maintenance process, including audits.
Leads, coaches, and mentors nonexempt and entry level exempt personnel.
Lead supplier audits using ISO 13485 or ISO 9001 guidelines
Analyze data to create improvement plans with suppliers
Excellent interpersonal skills.
A selfstarter, motivated and able to positively motivate others.
Focused, target driven with a positive, cando attitude.

Required Qualifications

Bachelor's degree in Engineering,
Minimum of 5 years of similar experience in the medical device FDA regulated industry

Desired Qualifications

Lead Auditor Certification preferred.
Fluent in English (both written and verbal)
Root Cause and Failure Investigation
Previous experience supporting external audits required (example: Notified Body or FDA)
Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO Risk Management) requirements, EU MDR requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Ability to work effectively in a fast paced and dynamic environment.