Senior Director, Product Quality & Validation

BioTalent; San Diego (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

BioTalent in San Diego, CA is seeking a Director of Product Quality Engineering to lead the site’s quality engineering and quality control organization. This hands-on leader will bring deep validation and statistics expertise, mentor a large team, and remain credible during FDA inspections.

The role reports to senior leadership and offers a clear path to raise the bar on quality across the site, with a base salary in the 200k–260k range plus bonus and industry-leading benefits.

Qualifications

• 15+ years of quality engineering and quality control in medical device/IVD manufacturing (FDA/ISO 13485)
• 10+ years of people leadership, including managing managers
• Hands-on validation experience with IQ/OQ/PQ and validation strategy
• Expert-level statistics: Cpk/Ppk, SPC, DOE, sampling plans
• ISO 14971 risk management, CAPA and root cause investigation
• Experience leading or supporting FDA inspections
• Knowledge of GD&T, mechanical inspection, drawings, tolerancing
• ASQ CQE preferred; Six Sigma Black Belt a plus

Responsibilities

• Lead, develop and mentor a team of people leaders and engineers, serving as technical leader
• Act as subject matter expert on statistics and process validation; guide capability analysis, SPC, validation strategy
• Oversee process validation, design controls, design quality and ISO 14971 risk management
• Sit on CAPA Review Board and drive root cause rigor and CAPA effectiveness
• Maintain NCR oversight
• Lead FDA and ISO inspection readiness; be calm and credible during inspections
• Partner with Supply Chain and R&D on supplier selection, auditing and performance
• Champion Lean Six Sigma and 5S across site
• Collaborate with Manufacturing, Operations, R&D and Regulatory to improve quality and business performance

Job description

BioTalent in San Diego, CA is seeking a Director of Product Quality Engineering to lead the site’s quality engineering and quality control organization. This hands-on leader will bring deep validation and statistics expertise, mentor a large team, and remain credible during FDA inspections.

The role reports to senior leadership and offers a clear path to raise the bar on quality across the site, with a base salary in the 200k–260k range plus bonus and industry-leading benefits.