Senior Quality Engineer - Quality Operations

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 3 weeks ago(9/7/2022 6:06 PM)
ID
2022-3829
Category
Quality

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. The company is focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment.

 

We started with a simple mission to help more patients suffering from debilitating pain and developed our proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally.

 

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Job Summary & Responsibilities

In this role reporting to the Director, Quality Operations, you bring your expertise in risk management, supplier quality, sustaining design changes and process validations. You will be responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. In this hands-on role, you will apply diversified knowledge of engineering, mechanical and software V&V, supplier management and quality principles/practices for implantable medical devices and accessories.

  • Responsible for execution of quality assurance and quality systems application within the department and across departments.
  • Quality lead on various projects by representing areas of Quality Assurance.
  • Lead Risk Management activities that include but not limited to: creating and updating Risk Management file in accordance with ISO 14971 requirements.
  • 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.
  • Assist 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

Role Requirements

  • Prior experience in Class-II or Class-III medical devices a must.
  • Bachelor's degree in a technical or science major, i.e. Mechanical Engineering, E.E. or Biomedical Engineering preferred.
  • Understanding of design and process changes in-house and at supplier sites, and associated impact to DHF.
  • 5+ years (7+ years preferred) of Quality/Regulatory experience in a medical device or other regulated industry working on Class-II and/or Class-III catheters, guidewires, implantable lead wires or similar patient contacting devices.

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.

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