QA Compliance Specialist 1

Nevro Corp.

Alajuela
Permanente
Tiempo completo

Hace 2 meses

About NevroNevro (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 & ResponsibilitiesThe QA Compliance Specialist I, is responsible for working cross-functionally to ensure maintenance and review of events and complaints, 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 adequate information to ensure proper documentation and closure of each complaint.
Follow up with internal and external customers for complaint data.
Assess complaint investigations for compliance and accuracy.
Collaborate with technical, Clinical, Field/Sales and/or returned product analysis teams to determine reporting eligibility.
Analyze events reported from multiple inputs to determine complaint status and regulatory reportability.
Ensure audit results are formally recorded and reported and CAPAs are documented.
Write and maintain SOPs, WI’s, audit reports and other documentation as required.
Identify, generate, and publish metrics and reports related to the Quality issues as well as departmental operational metrics.
Drive continuous improvement of the Quality Systems and Processes.
Performs other duties as required.

Role Requirements

Minimum: Associates degree with 1 year or more of working in a regulated med-device or pharma industry
Alternative: Bachelor’s degree in a technical, medical, or scientific background.

1 Year of relevant work experience is acceptable with Bachelor’s DegreeSkills and Knowledge

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 desired
Knowledge of 21 CFR Part 803, Medical Device Reporting desired
Willingness and capability to handle multiple projects and responsibilities
Must have good analytical and problem-solving skills
Working knowledge of Microsoft Office applications

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

Nevro Corp.

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