Company Overview: Our company is a leader in additive manufacturing, located in vibrant California. We are at the cutting edge of the industry with our innovative solutions, and we're on the lookout for an experienced technical Quality Director to enhance our team.

Job Overview: The Quality Director will oversee and implement quality control processes, procedures, and inspections to maintain and improve product quality while expanding our manufacturing capabilities. You will focus on developing and implementing quality measures, supporting product verifications, and collaborating with cross-functional teams to drive continuous improvement in operations. This role is crucial for ensuring that our products or processes consistently meet quality standards, customer expectations, and comply with industry regulations. Your efforts will help reduce defects, minimize rework, and boost overall product reliability and customer satisfaction.

Roles/Responsibilities:

• Company Culture and Mission:

  • Consistently apply core values (Integrity, Impact, Dedication) in decision-making and interactions. Use these values to align your actions with our mission.
  • Uphold and enhance our quality policy commitment through continuous improvement, customer focus, team collaboration, and compliance.

• Validation and Verification Testing:

  • Develop and execute validation tests for equipment, processes, or systems in the manufacturing environment, documenting outcomes to ensure compliance with established criteria.
  • Conduct risk assessments and take corrective actions to mitigate identified risks.

• Quality Control Inspections:

  • Support and perform inspections to ensure compliance with quality specifications and standards using various tools such as vision systems and gauges.

• Quality Control Processes:

  • Develop and monitor quality control procedures to adhere to quality standards.

• Defect Detection/Nonconformances:

  • Identify and resolve quality issues promptly, implementing corrective actions to prevent recurrence.

• Statistical Analysis:

  • Use statistical tools to make informed decisions about product and process quality.

• Calibration and Maintenance:

  • Schedule calibration and preventive maintenance to ensure equipment reliability.

• Documentation and Reporting:

  • Engage in root cause analysis and continuous improvement activities to enhance process efficiency.

• Training and Education:

  • Train personnel on quality control procedures and industry best practices.

• Compliance:

  • Ensure compliance with industry standards and regulatory requirements.

• Continuous Improvement:

  • Drive initiatives to enhance the efficiency and effectiveness of quality control processes.

Education and Experience:

• Bachelor’s degree in engineering or related field with 4-8 years relevant experience; Master’s degree preferred.
• Additional 3-8 years in quality control or related roles.
• Experience with quality control software and tools preferred.
• Six Sigma Certification, Black Belt preferred.
• Management experience preferred.

Competencies:

• Knowledge of ISO 13485 and FDA CFR 820 requirements.
• Strong understanding of quality control principles and methods.
• Proficient in measurement and inspection equipment.
• Detail-oriented with excellent problem-solving skills.
• Effective communication and teamwork abilities.

Benefits Include:

• Medical, Vision, and Dental Insurance
• Short Term Disability
• 401(k) plus match
• Vacation days
• Paid holidays