Quality System Integration Specialist – Contractor

About Nevro:

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 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®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response¹.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. 

Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Responsible for integrating, supporting, and maintaining the Quality Systems at VYRSA and Nevro within the requirements of FDA’s Quality System Regulations (QSR), ISO 13485 (ISO), and other international standards.

This position is responsible for providing Quality and Integration support including process and procedural alignment activities, systems testing, records migration, and assisting with shared duties as required.

Integration Support

• Support the integration of the VYRSA and Nevro Quality Systems.
• Create, revise, and review Quality System documents to maintain compliance with FDA, EU and other national and international regulations and standards.
• Leverage existing and support ongoing GAP analysis between existing procedures. Work with Subject Matter Experts (SME’s) consolidate content.
• Support the preparation & migration activities for VYRSA Documents and Records as they are moved into Nevro electronic systems.
• Assist with validation testing, record uploads, and ongoing user education.

Document Control and Records

• Support Document Control functions and responsibilities.
• Ensure the consistency and quality of newly aligned documents by formatting, editing, and proofreading documents prior to routing.
• Route documents within the relevant Quality System including the processing of new documents, revision of documents, and obsolescence requests.
• Interface with staff to answer questions regarding SOPs, change controls, document routing and relevant records updates.

Training

• Assist in the integration of the VYRSA training matrix, upload of historical training records, and assignment of training curricula.
• Support the redesign of the training matrix model and establishment of updated curricula in the relevant electronic systems.
• Ensure staff are notified and training is completed upon revision of applicable documents.

Project Management

• Provide back-up to the VYRSA Management Representative on integration activities to bring the three Quality Systems together.
• Maintain trackers and project schedules as requested.

• Bachelor’s degree, preferably in life sciences and a minimum of 5+ years’ experience in an FDA regulated medical device environment, or equivalent combination of studies and relevant work experience.
• Excellent word processing, verbal and written communication skills.
• Ability to work independently and in collaboration with other team members.
• Knowledge of FDA regulations for medical devices and ISO 13485
• Perform other duties as assigned.

• Knowledge of documentation systems, specifically new product development (specifications, protocols, plans, reports, software, validation data, Design History Files), Quality Systems (procedures, forms, records), and manufacturing (Bill of Materials, Procedures, Device History Records, Device Master Records).
• Experience with electronic documentation and training systems.
• Direct experience maintaining procedures as they relate to the FDA Quality System Regulations for Medical Devices and Tissue product. Awareness of EU regulations (ISO13485) preferred.
• Experience with 21 CFR Part 11 and Computer/Quality System Software management methods preferred.
• Strong technical capability, verbal and written communication skills and effective interpersonal skills.
• Ability to work independently with minimum oversight.
• Ability to multitask, prioritize and meet deadlines.
• Above average organizational skills, detail-oriented while being flexible, able to adapt to changing priorities is required.
• Proficiency in Microsoft Office, Word, Excel, Project, as well as exposure to technical document source applications such as Adobe Acrobat, SolidWorks, and Illustrator is recommended.
• Ability to communicate well with all levels of staff and present data to Management when needed.

$40 - $50. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.”

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.