Senior Director, Quality Assurance and Compliance

6 days ago


Brooklyn Park, Minnesota, United States CVRx Full time
Job Description

About CVRx

CVRx is a pioneering company that develops innovative medical technologies to improve patient care. We are committed to delivering high-quality products and services that meet the needs of our customers.

Job Summary

We are seeking a highly skilled Senior Director, Quality Assurance and Compliance to lead our quality systems and assurance efforts. The successful candidate will provide strategic leadership and direction to ensure the development, implementation, and maintenance of our quality assurance systems and activities.

Key Responsibilities

  • Quality System Leadership
    • Develop and implement quality policies, procedures, and standards to ensure compliance with regulatory requirements.
    • Lead the development and maintenance of quality management systems, including change control, vendor qualification, and records management.
    • Ensure the effective implementation of quality training programs and competency assessments.
  • Quality Audits and Compliance
    • Plan, conduct, and report on internal and external quality audits to ensure compliance with regulatory requirements.
    • Develop and implement corrective and preventive action plans to address audit findings and deficiencies.
  • Regulatory Affairs
    • Ensure compliance with regulatory requirements, including ISO 13485, MDSAP, and U.S. QSR 21 CFR 820.
    • Develop and maintain relationships with regulatory agencies and industry partners.
  • Team Leadership
    • Lead a team of quality professionals to ensure the effective implementation of quality systems and activities.
    • Develop and implement training programs to ensure the competence of quality team members.

Requirements

  • Education
    • College degree in engineering, science, or medicine.
  • Experience
    • Minimum 15 years of experience in quality assurance and/or quality systems, with at least 5 years in medical devices.
    • Experience with quality system auditing and regulatory compliance.
  • Skills
    • Strong leadership and communication skills.
    • Ability to develop and implement quality policies, procedures, and standards.
    • Experience with quality management systems, including ISO 13485 and MDSAP.

Working Conditions

  • Normal office conditions.
  • Travel up to 10% of time, including some international travel.

Benefits

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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