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.
Job Summary & ResponsibilitiesJOB SUMMARY
Perform inspection at various stages of production of the product from raw material, sub-assemblies and final assemblies to assure quality and conformance to specification and procedural requirements. This position is also responsible for providing QA support, where needed, but not limited to QA Operations.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Applying knowledge of Inspection and GMP requirements on a daily basis, the duties and responsibilities for this position include, but are not limited to, the following:
Carry out inspection activities to ensure the quality of products and raw materials used in the production of products to meet customer or internal standardsResponsible for the correct handling of the corresponding fixtures and equipment.Correct use of quality inspection records following GMP requirements. Ensure the consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storage.Maintain and archive documents in an organized and retrievable state (manual or electronic) for compliance to procedures, regulations and standardsSafekeeping all quality records of In-Process Inspection.Schedule periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations.Communicates corrections and improvement opportunities Responsible to ensure timely release of subassemblies and assemblies by executing, reviewing and approving Device History Records (DHRs) and ERP transactions per internal requirementsResponsible for the control of nonconforming material (identification, segregation)Interface with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements.Labelling and segregation of components and assembliesNotify cross functional departments including Production, Quality and Purchasing on component/assembly dispositions and/or material holds.Managing component/assembly disposition and queries using the QAD system.Support with External Audits activities when required and as directed. Perform other duties as assigned.Responsible for the release of subassemblies, assemblies and final assemblies.Ensure compliance of the organization's management systems to guarantee effectiveness and adherence to established policies, standards, and regulatory requirements. Role Requirements
EXPERIENCE
Quality Inspector or advanced studies in relevant technical discipline required.No fewer than three (3) years of directly related experience, having experience in a class II or III medical device environment quality inspection is preferred, complaints lab inspection or receiving inspection is also preferred, inspection small components using a microscope is preferred. Experience in the medical device industry and with knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485) is preferred; Experience with QAD preferred.Prior experience working with US companies is a plus.IPC-A-610 certification or knowledge in medical device component welding through resistance welding, spot welding or laser welding is a plus.Handling of electrical components is a plus.Experience with ESD processes is a plus. Skills and Knowledge Strong communication skills, both verbal and written. Bilingual English and Spanish speakers are preferred.Ability to read and interpret documents such as job travelers, plans, sketches, diagrams and other procedural materials and documents.Fundamental geometry, fractions, percents, relationships and measurementsTime-effective / organizational management skills Ability to work independently with little supervision, as well as in "team" workEffective interpersonal skills and dexterity on the job with a culturally diverse employee populationKnowledge of measurement instruments, sample plans is a plusExperience with inspecting small parts under magnification is a plus
Work environment and physical requirements:
Production area / clean roomSome exposure to noisy equipmentTo perform this job successfully, an individual must be able to perform all essential job tasks and functions satisfactorily with or without reasonable accommodations.Target Pay Range
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.
EEO StatementNevro 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.
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