Quality Systems Engineer

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.

Applying knowledge of QSR and GMP requirements on a daily basis, the duties and responsibilities for this position include, but are not limited to, the following:

• Responsible for the development and maintenance of quality programs, systems, processes and procedures to ensure internal and regulatory standards compliance requirements are followed, implemented per requirements.

• Manage the coordination of Quality (monthly and quarterly) metrics, analyze trends, drive continuous process improvements and generate reports related to the Quality System performance:  

• Preparing/support site Quality Management System metrics (QMR, CAPA, NCMR, IAs, etc.), presentation and post-review minutes and action items.
• Perform site data analysis
• Preparing and issuing periodic Quality data and dashboards to Management and HQ.

• Support/Administrate CAPA/IA program by maintaining the strategy, systems and tools to ensure a robust corrective and preventive actions, tracking of Action completion, and assessment of effectiveness, as appropriate.
• Support and/or Lead the coordination of internal/external/supplier Quality System audits. Participates in internal and supplier and external regulatory site visits, inspections, and audits. Including ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, follow up to ensure audit action items are closed, etc.
• Lead cross functional teams to execute Quality System initiatives. As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)

• Draft, review, and update QMS documents including the processing of new document and document revision requests.
• Ensure the consistency and quality of documents by editing and proofreading documents prior to release.
• Schedule and execute periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations.
• Supports investigating and resolving system nonconformance’s (related to Quality Systems).
• Responsible for new hire orientation related to quality topics.

• Apply proactive, systematic problem-soling methodologies in identifying, prioritizing, communication and resolving quality system issues.
• Perform other duties as assigned.

• Bachelor’s degree in relevant technical discipline required, advanced degree preferred;
• No fewer than one (1) year of directly related experience in Quality Systems in the Medical Device industry;
• Experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485);
• Internal Audit Certification or confirmed auditing experience is preferred;
• Prior experience working with US companies a plus.

• Knowledgeable with the FDA Submission process, ISO Requirements and QSR requirements;
• Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization;
• Strong working knowledge of quality system processes and audits (internal and external);
• Strong technical capability, effective interpersonal skills and be able to work independently;
• Knowledge of documentation systems, specifically quality system (procedures, forms, quality records), among others;
• Experience with electronic documentation systems such as Arena, EtQ, preferred;
• Must be organized, detail-oriented and adaptable;
• Cross-functional collaboration with Quality, Regulatory, Engineering, Manufacturing, Supply Chain, etc;
• Strong problem-solving, organizational, analytical and critical thinking skills;
• Ability to communicate fluently in Spanish & English, both verbal and written;
• Proficiency in Microsoft Office, Access, Excel, Project, as well as exposure to technical document source applications such as Power BI, Adobe Acrobat, SolidWorks, and Illustrator is recommended;
• Ability to communicate well with all levels of staff and present data to Management when needed;
• Ability to multi-task, work under pressure and meet deadlines required.

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.