Senior Quality Assurance Compliance Specialist - Redwood City, CA, United States - Nevro Corp.

Description

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.

Nevros 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, Nevros latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response 1 .Nevros 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.

The Sr QA Compliance Specialist is responsible for providing subject matter expertise in Post Market Quality (PMQ) activities such as complaint investigations, MDR and vigilance reporting, trending/monitoring of PMQ data, and auditing internal complaint records.

The Sr QA Compliance Specialist works cross-functionally to ensure maintenance and review of complaint files, fulfillment of department goals and objectives, reporting of Medical Device Reports (MDRs) and adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports complaint handling in internal and external audits and inspections.

• Perform tasks to obtain information to ensure proper documentation of complaint investigations, including following up with internal and external customers.
• Assess complaint investigations for compliance and accuracy.
• Collaborate cross-functionally on complaint investigations.
• Analyze events reported from different sources to determine risk assessments and regulatory reportability.
• Drive continuous improvement of the quality systems and processes.
• Ensure audit results are formally recorded and reported and CAPAs are documented.
• Write and maintain SOPs, WIs, audit reports and other documentation as required.
• Identify, generate, and publish metrics and reports related to quality issues.
• Submit Medical Device Reports (MDR) as required per internal procedures and FDA regulations.
• Submit vigilance reports as required per internal procedures and international regulations.
• Monitor and manage complaint handling processes, escalating to management as appropriate.
• Analyze and trend post-market surveillance data.
• Generate recommendations and conclusions from Post Market Quality data analysis.
• Provide back-room assistance in regulatory audits.
• Collaborate with other departments to make sure PMQ data is being incorporated into the Quality System.
• Be available as a knowledge resource/ subject matter expert (SME) to other team members.
• Assist in field action activities as needed.
• Audit internal complaint records for quality and training purposes.
• Write, review and submit formal investigation result letters to health care providers.
• Other duties as assigned.

• 5+ years of working experience in the medical device industry or in another heavily regulated industry.
• Bachelors degree or higher, preferably a medical or technical degree.
• Experience with medical device complaint handling desired.
• Experience in FDA Medical Device Reporting (MDR) desired.
• Experience with international reporting requirements, including the European Medical Device Regulation (EU MDR) and vigilance reporting requirements desired.
• Regulatory audit experience in the medical device or pharmaceutical industry desired.

• Excellent written and oral communication skills along with good presentation and technical writing.
• Ability to communicate effectively with cross-functional team and with all levels of the organizations.
• Can work independently in a team environment.
• Takes initiative and proactively seeks quality solutions through continuous improvement.
• Knowledge of 21 CFR Part 820, Quality System Regulations.
• Knowledge of 21 CFR Part 803, Medical Device Reporting.
• Willingness and capability to handle multiple projects and responsibilities.
• Must have good analytical and problem-solving skills.
• Working knowledge of Microsoft Office applications
• Experience with data analytics using Tableau or any other equivalent data platforms desired.
• Conflict resolution skills.

$108,182 - $148,750. 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.