Provides leadership in the development, implementation, and maintenance of CVRx’s quality assurance systems and activities. Defines and specifies the implementation of standards, methods, processes, quality training, quality programs and the quality auditing of the CVRx’s products, processes, and services. Through leadership, knowledge, and communication, the Vice President of Quality Assurance & Quality Systems is a driving force in the company’s pursuit of excellence in all aspects of our company.

Key Duties and Responsibilities:

• Serve as the management representative to the quality system.
• Oversee quality systems to include change control, vendor qualification, records management, equipment and process validation, internal and external audits, SOPs, process improvement, change control, and data review support.
• Facilitate the development of corporate quality policies and auditing practices as well as authorize their implementation.
• Manage the successful ongoing ISO 13485 certification and ensure the certification remains intact; including U.S. Quality System Regulation (QSR) 21 CFR 820 requirements and other country requirements as we enter into those markets.
• Assist organizations throughout the company to identify, document, and implement Quality Systems, including policies, processes, procedures, work instructions, and forms that ensure compliance to U.S. QSR 21 CFR 820, Good Manufacturing Practices (GMP), ISO 13485, EU Medical Device Regulation (MDR), and other worldwide regulatory requirements where devices are being marketed.
• Coordinate, collaborate and communicate both internally and with our customers and suppliers to monitor and resolve problems/complaints and execute projects in a timely and effective manner.
• Develop key quality assurance metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies.
• Ensure training, as related to quality systems, procedures, and operator certification is effective and completed.
• Ensure compliance with worldwide regulatory standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity.
• Perform miscellaneous duties as assigned by the CVRx management.

Education & Experience

Required:

• College degree in engineering, science, medicine or equivalent.
• Minimum 15 years' experience and in-depth background in quality assurance and/or quality systems, at least 10 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.
• Excellent communication, organizational, and leadership skills.
• Knowledge of medical terminology.

Preferred:

• Extensive knowledge of documentation and management systems like Agile, ERP/MRP and Windchill software applications.

Working Conditions:

• Normal office conditions.
• Travel up to 15% of time including some international travel.
• May be required to be fully vaccinated against the COVID-19 virus and other diseases.

Employee 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 options.
• 12 company paid holidays per year PTO.
• Paid time off for new parents.
• Company paid life insurance & disability.