Director, Quality Management

AccuScan SciencesMilpitas, CA

About The Position

The Director of Quality oversees the development, implementation, and maintenance of quality assurance programs and processes to ensure compliance with regulatory standards and drive continuous improvement across the organization.

Requirements

  • Bachelor's degree in a relevant field; advanced degree preferred.
  • Proven experience in quality management, preferably in a regulated industry.
  • In-depth knowledge of quality assurance methodologies, regulations, and standards.

Responsibilities

  • Develop and implement quality assurance policies, procedures, and standards aligned with industry regulations.
  • Monitor and assess processes to maintain compliance with relevant quality standards (e.g., FDA, ISO).
  • Identify areas for quality improvement and lead initiatives to enhance operational efficiency and effectiveness.
  • Implement best practices and quality improvement methodologies.
  • Conduct internal audits to evaluate adherence to quality standards and regulatory requirements.
  • Collaborate with regulatory agencies and oversee external audits.
  • Develop training programs and materials to ensure staff understanding and compliance with quality standards.
  • Provide guidance and support to teams to improve quality-related processes.
  • Establish key performance indicators (KPIs) and metrics to measure and report on quality-related activities.
  • Prepare regular reports and presentations for senior management regarding quality performance.
  • Identify potential risks to quality and develop strategies to mitigate and manage these risks.
  • Additional duties as assigned.
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