Director, Quality Management

AccuScan Sciences; Milpitas (CA); On-site; USD 140,000 - 220,000; Full time

Job summary

AccuScan Sciences seeks a Director of Quality to oversee the development, implementation, and maintenance of QA programs ensuring regulatory compliance and driving continuous improvement across the organization.

The role requires strong expertise in quality systems, regulatory standards (FDA/ISO), and leadership to guide cross-functional teams in quality initiatives and risk management. California-based, with opportunities to influence strategic quality outcomes.

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

• Oversee development and maintenance of QA programs aligned with regulatory standards.
• Identify quality improvement opportunities and lead initiatives to increase efficiency.
• Conduct internal audits and collaborate with regulatory agencies for external audits.
• Develop training programs to ensure staff understanding of quality standards.
• Establish KPIs and reporting for senior management on quality performance.
• Identify potential risks to quality and develop mitigation strategies.
• Additional duties as assigned.

Skills

Quality Assurance

Process Improvement

Auditing & Compliance

Quality Metrics

Risk Management

Training & Development

Education

Bachelor's degree in 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.