Director, Quality Management

AccuScan Sciences; Milpitas (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

AccuScan Sciences is seeking a Director of Quality to oversee the development, implementation, and maintenance of QA programs ensuring regulatory compliance and ongoing process improvement across the organization.

The role leads QA policies, audits, training, and metrics, partnering with cross-functional teams to drive quality, while preparing senior management reports on performance and risk; the position requires strategic thinking and strong regulatory expertise to manage external audits.

Qualifications

• 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 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.

Skills

Quality management

Regulatory compliance

Leadership

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Job description

JOB SUMMARY

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.

KEY RESPONSIBILITIES

• Quality Assurance:
  • 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).
• Process Improvement:
  • Identify areas for quality improvement and lead initiatives to enhance operational efficiency and effectiveness.
  • Implement best practices and quality improvement methodologies.
• Auditing and Compliance:
  • Conduct internal audits to evaluate adherence to quality standards and regulatory requirements.
  • Collaborate with regulatory agencies and oversee external audits.
• Training and Development:
  • 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.
• Quality Metrics and Reporting:
  • 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.
• Risk Management:
  • Identify potential risks to quality and develop strategies to mitigate and manage these risks.
• Additional duties as assigned.

Required

• 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.

COMPETENCIES

• Quality Assurance
• Process Improvement
• Auditing and Compliance
• Quality Metrics
• Risk Management
• Training and Development

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Frequently required to sit.
• Frequently required to stand.
• Frequently required to utilize hand and finger dexterity.
• Frequently required to talk or hear.