Director, Product Quality Engineering

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

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 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