Job Description
Director of Product Quality Engineering | San Diego, CA (100% onsite)
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Summary
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We've been exclusively retained by an established diagnostics company to find a Director of Product Quality to lead its San Diego site's quality engineering and quality control organization. It's a hands-on leadership role for an engineer at heart: someone with deep validation and statistics expertise who can answer the tough technical questions, mentor a large team, and stay calm and credible during FDA inspections.
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The site is in a period of growth and change, having recently added several key leaders that are incredibly high caliber. You'd join a leadership team of decision makers and play a key role in raising the bar on quality across the site, with real room to grow.
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💰 $200K–$260K base + bonus and industry-leading benefits
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Scope
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- Leads a 36-person Quality Engineering and Quality Control organization
- 4 direct reports: 2 Senior Managers and 2 Specialized Engineers
- Oversees: incoming QC, supplier quality, Quality Control, design quality, and product quality and reliability
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Responsibilities
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- Lead, develop and mentor a team of people leaders and engineers, and be the technical leader the team looks up to
- Serve as the site's subject matter expert on statistics and process validation, guiding the team on capability analysis, SPC and validation strategy week to week
- Oversee process validation, design controls, design quality and ISO 14971 risk management for new and sustaining products
- Sit on the site's CAPA Review Board alongside senior Operations and R&D leaders, driving root cause rigor and CAPA effectiveness across all phases
- Maintain oversight of nonconformance management (NCRs handled by QC)
- Lead FDA and ISO inspection readiness, and act as a calm, credible point of contact during inspections and audits
- Partner with Supply Chain and R&D on supplier selection, auditing and performance monitoring
- Champion Lean Six Sigma and 5S initiatives across the site
- Work closely with Manufacturing, Operations, R&D and Regulatory to improve quality and business performance
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Requirements
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- BS in Engineering strongly preferred; BS in a technical discipline required
- 15+ years of quality engineering and quality control experience in medical device or IVD manufacturing (FDA/ISO 13485)
- 10+ years of people leadership, including managing managers
- Hands-on validation experience, including authoring process validation protocols (IQ/OQ/PQ) and leading validation strategy
- Expert-level statistics in practice: process capability (Cpk/Ppk), SPC, DOE and sampling plans
- Strong foundation in ISO 14971 risk management, CAPA and root cause investigation
- Direct experience leading or supporting FDA inspections
- Working knowledge of mechanical inspection, engineering drawings, GD&T and tolerancing
- ASQ CQE strongly preferred; Six Sigma Black Belt a plus
- Lean / 5S experience a plus
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What success looks like
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- Credible and hands-on: can answer technical questions on validation, statistics and drawings, not just delegate them
- Calm under pressure: unruffled during inspections, and a steady mentor to the team
- Courageous and transparent: comfortable challenging and being challenged in a room of senior decision makers
- Influential: builds trust and alignment across Operations, R&D and Quality
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