Senior Director of Quality Assurance and Quality Systems

4 hours ago

Brooklyn Park, Minnesota, United States CVRx Full time
Job Title: Senior Director, Quality Assurance

At CVRx, we are seeking a highly experienced Senior Director of Quality Assurance to lead our quality assurance and quality systems initiatives. As a key member of our team, you will be responsible for developing, implementing, and maintaining our quality assurance systems and activities.

Key Responsibilities:
  • Provide leadership in the development and implementation of quality assurance systems and activities.
  • Define and specify the implementation of standards, methods, processes, quality training, quality programs, and quality auditing of products, processes, and services.
  • Oversee quality systems, including change control, vendor qualification, records management, equipment and process validation, training and competency programs, and documentation.
  • 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.
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.
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 strongly preferred.
  • Basic knowledge of Agile and Windchill software applications.
  • Experience working with Class III active implantable medical devices strongly preferred.
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.
Benefits:
  • We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has the opportunity to make a significant impact in an exciting purpose-driven startup environment.
  • We also offer a competitive benefits package, details listed below:
    • 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.

CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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