Director, Product Quality Engineering

Director of Product Quality Engineering | San Diego, CA (100% onsite)

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

Summary

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.

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.

$200K–$260K base + bonus and industry-leading benefits

Scope

• 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

Responsibilities

• 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

Requirements

• 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 xhyhwjd 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

What success looks like

• 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