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 Senior Director 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, training and competency program and documentation, internal and external audits, standard operating standards (SOPs), process improvement, change control, and data review support.
• Facilitate the development and update of corporate quality policies and auditing practices as well as authorize their implementation.
• Manage the successful ISO 13485 and MDSAP certification and ensure the certification remains intact; including U.S. 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, ISO 13485, EU MDR, and other worldwide regulatory requirements where devices are being marketed.
• Assist these organizations in the development and updates of departmental performance scorecards.
• Schedule and lead regular management reviews per SOP requirements.
• Coordinate, collaborate, and communicate both internally and with our customers and suppliers to 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.

Required:

• 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.

Preferred:

• MBA degree.
• Local candidates or those willing to relocate strongly preferred.
• Excellent communication, leadership, and organizational skills.
• Experience working with electrical implantable medical devices.
• Basic knowledge of Agile and Windchill software applications.

Working Conditions:

• Normal office conditions.
• Travel up to 10% of time including some international travel.
• May be required to be fully vaccinated against the COVID-19 virus and other diseases.

• 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.

This role is perfect for a highly skilled professional who thrives in a fast-paced, innovative environment and is passionate about making a significant impact in the field of cardiovascular health. Join us at CVRx and be at the forefront of transforming patient care through cutting-edge technology.