Senior Director, Quality Assurance & Quality Systems

July 10

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CVRx | Barostim

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CVRx’s Barostim is a breakthrough technology that stimulates the body’s natural baroreflex to treat heart failure

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Description

• 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

Requirements

• College degree in engineering, science, medicine or equivalent • Completion of a Quality System Audit Program or experience in Quality System auditing • Minimum 15 years' experience and in-depth background in quality assurance and/or quality systems, at least 5 years of which are in medical devices • Experience with QSR/MDR/GMP/ISO and applicable international standards and regulations as required by specific country markets • Knowledge of medical terminology

Benefits

• Company Paid Health & Dental Insurance options • Company contributions to an HSA if enrolled in a high deductible plan • 401(k) with company match • Employee stock purchase plan & stock option grants • 12 company paid holidays per year + PTO • Paid time off for new parents • Company paid life insurance & disability • Unlimited growth opportunities • Training & learning opportunities • Flexible Schedules