• GD&T, APQP, FMEA, Control Plans, PPAP, Risk Management, Audits, Management Reviews, and Dfx.
• Process Capability, SPC, Data Analysis, DOE and other Statistical tools.
• 21 CFR 820, GMP, ISO 13485, AS9100, and ISO 9001 standards.
• Lean principles and practices.
• Audit experience in Medical, Aerospace, or Automotive industry.
• Engineering change controls, and configuration management.
• Defines and implements divisional quality strategies, and serves as the face of quality, both internal and external to the organization.
• Establishes and has accountability for divisional quality objectives, quality management system and CAPA board.
• Matrix responsibilities for site quality leadership and acts as a partner to the site leadership in achieving operational objectives.
• Responsible for supplier quality performance.
• Maintains and fosters strong relationship with customers, at multiple organizational levels.
• Good communication skills and maintains executive presence with customers and suppliers.
• Drives site quality certifications, and regulatory strategies. Interfaces with Auditors and Regulatory personnel during customer audits or third party audits.
• Has a good understanding of Operational Key Performance Indicators and basic financial metrics.
• Develops monitors and reports on key quality and performance indicators as related to Products and processes, across all sites.
• Understands and maintains the interrelationships among functions and with other business areas.
• Trusted advisor and partner to Precision Technologies leadership on product or process related issues, both internal and external.
• Active contributor to technology road map for Precision Technologies Tower.
• Works closely with the corporate quality and operational excellence team to align KPIs and strategic initiatives.
• Responsible for quality talent development across the division including selection of new hires, promotions, disciplinary actions up to and including terminations.
• Cross-site coordination for major customers.
• Keeps current on emerging trends in quality technologies and process control tools. Drives strategic initiatives on-boarding new technologies and closing gaps.10+ years of relevant quality experience. 5+ years in a leadership role in a multiple or large site.
• 4-year college technical degree.
• Six Sigma Black Belt through ASQ or reputable company.
• MBA or MS Industrial Engineering Preferred.