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Sr. Quality Engineer

Company: Nevro Corp
Location: Redwood City
Posted on: February 15, 2018

Job Description:

Title:-- ---- Sr. Quality Engineer

Department:-------- Quality

About Nevro

Nevro is a medical device company headquartered in Redwood City, California. We have developed HF10--- therapy, an innovative, evidence-based neuromodulation platform for the treatment of chronic pain.

We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has advanced the state of spinal cord stimulation (SCS).

The Nevro-- Senza-- SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

Sr. Quality Engineer

The Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Quality Engineer will apply diversified knowledge of engineering, software verification, supplier management and quality principles and practices for implantable medical devices and accessories. This position will report to Director, Quality.

Role Requirements


6+PC techniques, ations of years of Quality/Regulatory experience in a medical device or other regulated industry
Bachelor---s degree in-- a technical or science major
Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
Responsible for execution of quality assurance and quality systems application within the department and across departments
Project leader on various projects by representing Quality Assurance
Develop inspection and sampling plans
Work with outside testing laboratories and representatives from other departments
Perform/Lead Supplier Audits per audit and business requirements
Support with Supplier Management and transfer to manufacturing
Perform failure analysis by collaborating with Engineering on investigation as needed
Perform data collection and analysis to monitor test results trends
Perform, coordinate, review, approve, and/or provide guidance on:

Product Verification & Validation activities
Product specification
Computer System Validation
DHFs, DMRs, DHRs
Usability Study
Risk Management
External Standards--


Corrective action mitigation
Perform other duties as required


Skills and Knowledge


3 years auditing experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485), FDA Software guidance of Verification & Validation
Active Implantable Medical Device Directives (90/385/EEC)
Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance or similar standards, Soldering Standards (IPC-A-610)
Design Control process
Highly developed written and oral communication skills and be able to work in a team environment
Must have good problem solving skills and be able to work independently
Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation
Must be organized, detail-oriented and adaptable according to evolving situations at hand.

Keywords: Nevro Corp, San Francisco, Sr. Quality Engineer, Engineering, Redwood City, California

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