CVRx is a commercial stage, public (NASDAQ: CVRX) medical devices company  located in Minneapolis, Minnesota. The company has developed proprietary implantable technology for the treatment of high blood pressure and heart failure. Barostim™ triggers carotid baroreceptors - the body’s own natural blood flow regulation system - which signals the brain to regulate cardiovascular function. 

Patient Stories on CVRx:
The accounts and quotes of patients are genuine and documented. These stories represent a unique individual experience and does not provide any indication, guide, warranty or guarantee as to the response other people may have to CVRx technologies.

Barostim is a prescriptive device.  For a list of all potential benefits and risks go to www.cvrx.com/benefit-risk-analysis/

CVRx | Barostim

QA Engineer

• Provides leadership in the development, implementation, and maintenance of CVRx’s quality assurance systems and activities
• Define and specify the implementation of standards, methods, processes, and quality programs
• Manage the successful ISO 13485 and MDSAP certification and ensure the certification remains intact
• Assist organizations throughout the company to implement Quality Systems and ensure compliance to regulatory requirements
• Develop key quality assurance metrics and provide routine management reporting
• Ensure compliance with worldwide regulatory standards in quality systems

Senior Director, Quality Assurance & Quality Systems

Ensure quality and reliability for CVRx medical device product development and operations.

• Lead the charge in ensuring top-notch quality and reliability for new hardware, firmware, and software development projects.
• Take the helm in managing and documenting risk management activities, including reliability analysis, risk and hazard assessment, FMEA, and hazard analysis.
• Ensure seamless compliance with quality systems, risk management, and medical device standards, encompassing cybersecurity and usability, while maintaining crucial regulatory documentation.
• Review and green-light design and development documents, protocols, and reports for hardware, software, and firmware.
• Oversee design validation testing and reporting, generating essential protocols and reports.
• Craft or review Test Plans and Reports for production and qualification tests.
• Manage Nonconforming Material Reports, Deviations, and Product holds to bolster manufacturing operations.
• Document process FMEA and offer insights for process evaluations, qualifications, and validations.
• Spearhead supplier and component selection and qualification, along with equipment selection and qualification.
• Execute statistical analysis and provide sample size inputs for qualification/validation testing.
• Tackle CAPA issues, investigate returned products and complaints, and perform root cause analysis and health hazard assessments.
• Produce and review non-product software documentation related to field support, manufacturing, and development applications.
• Assist with internal audits to ensure regulatory compliance.
• Drive continuous improvement strategies for quality functions.
• Conduct Gage R&R studies and meticulously document results.
• Embrace miscellaneous duties as assigned to uphold excellence in quality and reliability.

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