Sr Quality Systems Specialist - Change/Document Control

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 contributing, supporting, and maintaining the Change Control Quality System within the requirements of FDA’s Quality System Regulations (QSR) and ISO 13485 (ISO) for Class I, II, and III medical devices, implants, and surgical tools. Ensure that product and product related documents are processed in compliance with established procedures. This position will be based in our Costa Rica location with flexibility to work remotely one day a week. The role reports to the Associate Director of Quality Systems (based at Nevro headquarters in California).

• Manage and maintain the Change Control and Document Control functions and related responsibilities within a Product Life Cycle Management (PLM) system.
• Clearly and accurately communicate both verbally and in writing (English), with document originators, authors, editors, reviewers, and approvers when discrepancies are found.
• Give precise guidance to originators for the proper process to follow when to correct issues and/or discrepancies as they occur.
• Provide change control guidance as needed to co-workers within and outside Document Control.
• Create, revise and review Quality System documents to establish and maintain compliance with FDA, EU and other national and international regulations and standards.
• Responsible for ensuring departmental SOP & WI reviews are performed per requirements.
• Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals.
• Support projects associated with global process harmonization to ensure consistent document control practice at different sites.
• Release and maintain QMS documents including the processing of new documents and document revision requests.

• Ensure the consistency and quality of documents by editing and proofreading documents prior to release.

• Create and maintain department KPIs and monitor team performance.
• Identify, generate, and publish metrics and reports related to the creation and control of quality system documentation. Analyze trends and recommend process improvements as appropriate.
• Assist with audit activities as required, including follow-up activities.
• Perform other quality duties as assigned.

• Bachelor’s Degree, preferably in Business, English, or Life Sciences.
• 8+ years of experience in Quality, with Medical Device industry experience preferred.
• Excellent word processing, document formatting, and proofreading skills required.
• Excellent verbal and written communication skills (in English) and ability to support and oversee Spanish translations of English documentation.
• Ability to work independently and in collaboration with other team members.
• Knowledge of FDA regulations for medical devices and ISO 13485.

• Knowledge of documentation systems and subject matter, specifically new product development (protocols, reports, software, validation data, Design History Files), quality system (procedures, forms, quality records), and manufacturing documentation (Bill of Material, routers, procedures, Device History Records, Device Master Records).
• Experience with electronic systems such as Arena (PLM), Cornerstone (LMS) preferred.
• Direct experience maintaining procedures as they relate to the FDA Quality System regulations and EU regulations (ISO13485 preferred).
• Exposure of 21 CFR Part 11 and Computer/Quality System Software management methods.
• Strong technical capability, English 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, Access, 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

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.