Supplier Quality Engineer

hace 3 días

Tijuana, México Outset Medical A tiempo completo

**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 non-conforming 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 non-exempt 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 self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do 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 14971 (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.

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