Quality Director (Austin, TX)

Senior leadership role responsible for overseeing the organization's quality management system, ensuring compliance with regulatory standards, and driving a culture of continuous improvement and excellence. This strategic position leads quality assurance and quality control initiatives across all operations to enhance product quality, customer satisfaction, and operational performance.

Responsibilities

• Strategic Quality Leadership
  • Develop and implement comprehensive quality strategies aligned with organizational goals and industry best practices
  • Establish quality vision, mission, and objectives that support business growth and customer satisfaction
  • Lead the modification and maintenance of the existing Quality Management System (QMS) to ensure alignment with the organization during growth
  • Define quality metrics, KPIs, and dashboards to monitor organizational performance
  • Partner with executive leadership to integrate quality principles into strategic planning
  • Allocate resources and budgets to support quality initiatives and improvement projects
• Quality Management System & Compliance
  • Ensure QMS compliance with relevant standards (ISO 9001, ISO 13485, ISO 14001, AS9100, etc.)
  • Oversee internal and external audits, managing audit schedules, findings, and corrective actions
  • Maintain relationships with regulatory bodies and manage regulatory inspections
  • Lead certification and recertification activities for quality standards
  • Develop and enforce quality policies, procedures, and work instructions
  • Monitor changes in regulatory requirements and ensure organizational compliance
• Quality Assurance & Control
  • Oversee quality assurance activities including process validation, qualification protocols, and risk assessments
  • Direct quality control operations including inspection, testing, and release procedures
  • Establish incoming, in-process, and final inspection criteria and acceptance standards
  • Implement statistical process control (SPC) and other quality tools as appropriate
  • Manage non-conformance processes, including root cause analysis and corrective/preventive actions (CAPA)
  • Oversee supplier quality management and vendor qualification programs
• Continuous Improvement & Operational Excellence
  • Champion continuous improvement initiatives using Lean, Six Sigma, Kaizen, and other methodologies
  • Lead cross-functional teams in quality improvement projects and problem-solving activities
  • Analyze quality data to identify trends, systemic issues, and improvement opportunities
  • Implement process optimization strategies to reduce defects, waste, and variation
  • Develop and track cost of quality metrics including prevention, appraisal, and failure costs
  • Foster a culture of quality awareness and accountability throughout the organization
• Team Leadership & Development
  • Build, lead, and mentor a high-performing quality team including quality techs at multiple sites
  • Conduct performance evaluations, provide coaching, and support professional development
  • Ensure the quality function adapts in organizational structure and responsibilities as the organization grows
  • Recruit and retain top quality talent with appropriate technical expertise
  • Promote cross-training and knowledge sharing within the quality, operations, R&D, and supply chain departments
  • Champion employee engagement and empowerment in quality initiatives
• Customer & Supplier Relations
  • Serve as the primary quality liaison with customers regarding quality issues and requirements
  • Manage customer complaints, lead investigations, and implement corrective actions
  • Oversee supplier quality programs including audits, scorecards, and improvement plans
  • Collaborate with procurement to qualify new suppliers and evaluate supplier performance
  • Lead quality agreements and specifications development with customers and suppliers
• Risk Management
  • Develop and implement risk-based approaches to quality management
  • Conduct failure mode and effects analysis (FMEA) and other risk assessment activities
  • Establish risk mitigation strategies and contingency plans
  • Monitor and report on quality risks to executive leadership
  • Ensure product safety and manage product recalls or field actions when necessary
• Documentation & Reporting
  • Ensure comprehensive documentation of quality processes, procedures, and records
  • Prepare quality reports for executive leadership, board of directors, and regulatory authorities
  • Maintain document control systems ensuring version control and accessibility
  • Oversee management review meetings and quality system performance reviews
  • Communicate quality performance metrics and improvement initiatives across the organization

Requirements

• Required
  • Bachelor's degree in Engineering, Quality Management, Life Sciences, or related technical field
  • 10-15+ years of progressive quality management experience with at least 5 years in leadership roles
  • Extensive knowledge of quality management systems and regulatory requirements
  • Proven track record of leading successful quality initiatives and driving organizational change
  • Strong understanding of statistical methods, quality tools, and problem-solving techniques
  • Experience managing and leading large, cross-functional teams
  • Must have owned an ISO recertification event with strong hands-on knowledge
  • Excellent leadership, communication, and stakeholder management skills
• Preferred
  • Master's degree in Quality Management, Business Administration (MBA), Engineering, or related field
  • Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or Certified Quality Auditor (CQA) from ASQ
  • Six Sigma Master Black Belt or Black Belt certification
  • ISO 9001 Lead Auditor certification
  • Experience in highly regulated industries (oil and gas, pharmaceutical, medical device, aerospace, automotive, food & beverage)
  • Experience with digital quality management systems and Industry 4.0 technologies

Skills

• Quality Management Systems: ISO 9001, ISO 13485, ISO 14001, AS9100, IATF 16949
• Quality Tools: FMEA, Control Plans, MSA, SPC, DOE, 8D, 5 Why, Ishikawa Diagrams
• Continuous Improvement: Lean Manufacturing, Six Sigma, Kaizen, Total Quality Management (TQM)
• Quality Software: Minitab, JMP, ETQ, MasterControl, TrackWise, or similar QMS platforms
• Auditing: Internal auditing, supplier audits, regulatory inspections
• Statistical Analysis: Hypothesis testing, capability studies, regression analysis

Key Competencies

• Strategic thinking and business acumen
• Change management and organizational transformation
• Analytical and data-driven decision making
• Executive presence and influence
• Conflict resolution and problem-solving
• Cross-functional collaboration and relationship building
• Customer focus and service orientation
• Attention to detail and process rigor
• Adaptability and resilience
• Ethical leadership and integrity
• Communication and presentation skills at all organizational levels
• Cultural awareness and ability to lead diverse teams

Work Environment

• Leadership-level position with significant organizational influence
• Office-based with regular presence on production floor or operational areas
• May require domestic and international travel for audits, customer visits, or regulatory meetings
• Participation in industry conferences, regulatory forums, and professional organizations
• Flexibility for occasional after-hours work during audits or critical quality events

Pay

$145k - 165k per year (plus bonus & stock options)

Benefits

Comprehensive benefits package