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Senior Quality Engineer

Company: Nevro
Location: Redwood City
Posted on: January 15, 2022

Job Description:

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on providing innovative products that improve the quality of life of patients suffering from debilitating 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 impacted the lives of over 70,000 patients around the world.

Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ---65% of patients across six peer-reviewed clinical studies. The Senza - System, Senza II--- System, and the Senza - Omnia--- System are the only SCS systems that deliver Nevro's proprietary HF10 - therapy.

Job Summary & Responsibilities

The Sr. Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Sr. 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 Manager, Quality. 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
Support with Supplier Management and transfer to manufacturing. Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Perform/Lead Supplier Audits per audit and business requirements
Perform data collection and analysis to monitor test results trends
Perform failure analysis by collaborating with Engineering on investigation as needed
Perform data collection and analysis to monitor test results trends
Help with Medical device software development
Perform, coordinate, review, approve, and/or provide guidance on:
Product Verification & Validation activities
Computer System Validation
Product specification
DHFs, DMRs, DHRs
Usability Study
Risk Management
External Standards
Corrective action mitigation
Perform other duties as required

Role Requirements
5+ years of Quality /Regulatory experience in a medical device or other regulated industry
Bachelor's degree in a technical or science major

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) or Medical Device Regulation (MDR)
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, Redwood City , Senior Quality Engineer, Engineering , Redwood City, California

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