Senior Quality Engineer

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.
*Responsibilities:* The Senior Quality Engineer is responsible for Quality Assurance activities including but not limited to managing sustaining process lifecycle changes, supplier audit files and sterilization process.
This is a hands-on role where the Senior Quality Engineer will apply diversified knowledge of engineering, V&V, risk management, supplier management and quality principles/practices towards manufacturing of implantable medical devices & accessories.
This position will report to Director, Quality Engineering and intended to be hybrid role.
* Product area: Class-III spinal implants, sustaining products, mechanical/materials/hardware.
* Responsible for creating and maintaining supplier files: draft supplier audit plans, perform remote or on-site supplier audits, release audit reports, summarize supplier metrics and close out supplier corrective actions.
Serve as Supplier Quality lead.
* Responsible for partnering with Nevro, Costa Rica towards successful closure of non-conformances, supplier defects and timely production builds.
* Travel to external supplier sites and Nevro, Costa Rica facility: approximately 15% travel.
* Serve as EO Sterilization subject matter expert in compliance with ISO 11135 EO Sterilization requirements.
Review, update and maintain Nevro Sterilization SOP in compliance with latest FDA, EU & Global Regulatory requirements.
Monitor bioburden & endotoxin limits for released Nevro products.
* Review and complete supplier change notifications.
Assess any impact to form, fit and function impact on Nevro devices resulting from supplier process changes.
* Serves as Quality Lead/Quality Manager on Projects involving: BSI/Notified Body Questions, sustaining process changes and supplier process improvements.
* Develop inspection and sampling plans.
Review manufacturing process inspection documents and production test methods.
* Work with outside testing laboratories and representatives as needed.
* Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
* Perform data collection and analysis to monitor test results trends.
Review Post-Market Quality data on a regular cadence.
* Support completion of CAPAs, NCs, SCARs and deliverables for audit readiness in preparation for FDA and EU audits.
Collaborate with Design Quality, QMS and Post-Market Quality for successful audit outcomes.
* Partner effectively with R&D, PMO and Manufacturing for timely resolution of device/process defects and failure analysis.
* Draft and/or review health hazard evaluations as per applicable Nevro Risk Management requirements.
* Perform, coordinate, review, approve, and/or provide guidance on: * Process Validations: IQ, OQ, PQ * Product & process specifications * DHFs, DMRs, DHRs * Risk Management * External Standards * Corrective & preventive action * Other duties as assigned.
Qualifications: * 6 to 8 years of hands-on Quality experience in medical device industry with direct experience working on Class-II & Class-III medical devices.
* Bachelor's degree in engineering, any technical or science major.
* Excellent presentation skills: dashboard, summaries, statistical tools, and project planning.
* Demonstrate excellent communication, collaboration, and presentation skills.
Must have strong self-accountability in alignment with Nevro Quality Policy.
* Demonstrated knowledge of QSR 21 CFR 820/ ISO 13485 QMS.
Auditing experience in FDA regulated Class II or III medical device environment to QSR 21 CFR Part 820, EU MDR, and ISO 13485 quality systems.
* Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
Knowledge and application of ASQ CQE preferred.
Training on six sigma tools also preferred.
* Understand and working knowledge of ISO 14971, ISO 11135, ISO 10993, and similar related standards.
* Process Validation knowledge: IQ, OQ, PQ, Test Method Validation and Sampling Plans.
* Great team player with proven self-accountability.
* Must have strong problem-solving skills and be able to work independently.
* Working knowledge of Corrective Action & Prevention methodology for systemic nonconformity mitigations.
* Must be organized, detailed and adaptable.
Benefits: $104,375 - $143,516 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 ti Other Information: *This position will be located in our Redwood City, CA office location.
* Job Type: Full-time Pay: $104,375.
00 - $143,516.
00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Referral program * Tuition reimbursement * Vision insurance Schedule: * Monday to Friday Ability to commute/relocate: * Redwood City, CA 94065: Reliably commute or planning to relocate before starting work (Required) Work Location: In person