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
ScopeLeads a 36-person Quality Engineering and Quality Control organization4 direct reports: 2 Senior Managers and 2 Specialized EngineersOversees: incoming QC, supplier quality, Quality Control, design quality, and product quality and reliability
ResponsibilitiesLead, develop and mentor a team of people leaders and engineers, and be the technical leader the team looks up toServe as the site's subject matter expert on statistics and process validation, guiding the team on capability analysis, SPC and validation strategy week to weekOversee process validation, design controls, design quality and ISO 14971 risk management for new and sustaining productsSit on the site's CAPA Review Board alongside senior Operations and R&D leaders, driving root cause rigor and CAPA effectiveness across all phasesMaintain 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 auditsPartner with Supply Chain and R&D on supplier selection, auditing and performance monitoringChampion Lean Six Sigma and 5S initiatives across the siteWork closely with Manufacturing, Operations, R&D and Regulatory to improve quality and business performance
RequirementsBS in Engineering strongly preferred; BS in a technical discipline required15+ years of quality engineering and quality control experience in medical device or IVD manufacturing (FDA/ISO 13485)10+ years of people leadership, including managing managersHands-on validation experience, including authoring process validation protocols (IQ/OQ/PQ) and leading validation strategyExpert-level xzbcwsv statistics in practice: process capability (Cpk/Ppk), SPC, DOE and sampling plansStrong foundation in ISO 14971 risk management, CAPA and root cause investigationDirect experience leading or supporting FDA inspectionsWorking knowledge of mechanical inspection, engineering drawings, GD&T and tolerancingASQ CQE strongly preferred; Six Sigma Black Belt a plusLean / 5S experience a plus
What success looks likeCredible and hands-on: can answer technical questions on validation, statistics and drawings, not just delegate themCalm under pressure: unruffled during inspections, and a steady mentor to the teamCourageous and transparent: comfortable challenging and being challenged in a room of senior decision makersInfluential: builds trust and alignment across Operations, R&D and Quality