Sr. Manager, Design Assurance Engineering
$151,700–$185,400 year
On-siteBrea, California, United States or Pomona, California, United States
Job Summary
Lead global Design Assurance and Supplier Quality teams, driving product quality, regulatory compliance, and innovation across the full lifecycle of dental electromechanical devices. Set strategic direction for quality systems, harmonizing processes across regions while championing automation, data analytics, and AI-driven solutions. Own global design quality strategy, acting as quality approver at design reviews and tollgates to ensure alignment with FDA, ISO 13485, and other regulatory requirements. Oversee supplier qualification, auditing, performance monitoring, and SCAR processes, leading complex root cause investigations and CAPA implementation. Partner cross-functionally with R&D, Manufacturing, and Supply Chain to integrate quality into product realization and enable successful global scale-up. Travel up to 15% domestically and internationally to support global operations.
Required Qualifications
- Bachelor's degree in Engineering
- Minimum 10 years of progressive relevant experience in a highly regulated industry (i.e. FDA, ISO)
- Minimum 5 years of leadership experience overseeing direct reports
- Strong leadership presence with the ability to influence across all organizational levels
- Deep knowledge of FDA regulations (21 CFR 820/QMSR), ISO 13485, design controls, and risk management (ISO 14971)
- Expertise in supplier quality management, including audits, qualification, and SCAR/CAPA processes
- Experience with validation (IQ/OQ/PQ), statistical methods, and continuous improvement (Lean, Six Sigma)
- Strong problem-solving and decision-making skills with a proactive, risk-based mindset
- Excellent English communication and technical writing skills
- Travel up to 15% domestically and internationally to support global operations
Desired Qualifications
- Master's degree
- Proven global experience in a matrix environment
- Experience in medical devices, preferably dental devices or materials
- Proficiency in digital quality systems and emerging technologies (automation, analytics, AI)
- Professional certifications (ASQ CQE, CQA, Six Sigma Black Belt)
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