Head of Quality

22 hours ago


NC United States Hobson Prior International Ltd Full time

Hobson Prior is seeking a Head of Quality for a role in the medical devices sector. This position focuses on ensuring high standards of quality and compliance for medical products. The successful candidate will be responsible for maintaining quality systems, managing audits, and leading a team to uphold product safety and effectiveness.

Responsibilities:

  1. Develop and maintain a quality management system to ISO 13485.
  2. Ensure products meet regulatory standards.
  3. Lead audits and manage corrective actions.
  4. Oversee risk management from design to post-market.
  5. Act as a liaison to resolve quality issues.
  6. Monitor key quality metrics.
  7. Oversee product testing and validation.
  8. Manage supplier quality programs.
  9. Collaborate with teams to address quality issues and drive improvements.
  10. Lead and mentor the quality team.

Key Skills and Requirements:

  1. Strong working background in quality assurance/control.
  2. 8+ years experience in Medical Devices and 4+ years experience in managing teams.
  3. Knowledge of regulatory standards (FDA, ISO, EU MDR).
  4. Experience with quality management systems and risk management.
  5. Ability to prepare and maintain regulatory submissions.
  6. Excellent communication and leadership skills.
  7. Relevant certifications are a plus.
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