Head of Quality Assurance Operations

1 week ago


Brooklyn Park, Minnesota, United States CVRx Full time
Position Overview

As the Director of Quality Assurance & Quality Systems at CVRx, you will be instrumental in leading the establishment, execution, and upkeep of quality assurance frameworks and initiatives. Your primary responsibility will be to articulate and delineate the implementation of standards, methodologies, processes, and quality training to uphold excellence across all facets of our organization.

Core Responsibilities:

  • Act as the management representative for the quality system.
  • Supervise quality systems encompassing change control, vendor qualification, records management, equipment and process validation, internal and external audits, among others.
  • Drive the formulation and revision of corporate quality policies and auditing methodologies.
  • Manage ISO 13485 and MDSAP certifications to ensure adherence to compliance standards.
  • Support teams in the creation and implementation of quality systems that fulfill regulatory obligations.
  • Establish key quality assurance metrics and deliver management reports.
  • Guarantee compliance with global regulatory standards across various domains.
  • Execute additional responsibilities as assigned by CVRx leadership.

Qualifications:

  • Bachelor's degree in a relevant discipline.
  • A minimum of 15 years of experience in quality assurance, with at least 5 years in the medical device sector.
  • Familiarity with QSR/MDR/GMP/ISO and international standards.
  • An MBA degree is preferred.
  • Exceptional communication, leadership, and organizational capabilities.

Work Environment:

  • Standard office environment.
  • Travel may be required up to 10% of the time, including potential international travel.
  • Full vaccination against certain diseases may be necessary.

Employee Benefits:

  • Health & Dental Insurance options covered by the company.
  • 401(k) plan with company matching.
  • Employee stock purchase plan and stock option grants.
  • 12 paid holidays annually plus PTO.
  • Paid leave for new parents.
  • Company-sponsored life insurance and disability coverage.
  • Unlimited opportunities for professional growth.
  • Training and development opportunities.
  • Flexible work schedules.

If you are a dedicated professional eager to make a significant impact in cardiovascular health, consider joining CVRx and contributing to our innovative technological advancements.



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