QMS Lead

Quality Management Leader (Onsite - Southern California)

Overview

A growing medical device company is seeking an experienced Quality leader to serve as both the on-site head of Quality at a primary manufacturing facility and the enterprise owner of the Quality Management System (QMS).

This role is responsible for ensuring a compliant, scalable, and harmonized QMS across multiple global locations, supporting regulatory requirements including ISO 13485, FDA QSR/QMSR, and EU MDR. The position plays a critical role in maintaining audit readiness, enabling operational excellence, and supporting expansion into new markets.

Reporting to the Head of Quality, this individual will lead site-level quality functions, oversee the corporate QMS, and act as a key liaison with regulatory authorities and notified bodies.

Key Responsibilities

Site Quality Leadership

• Lead all quality activities at the manufacturing site, including both daily operations and long-term strategy
  
  
• Manage and develop a cross-functional quality team (QA, Quality Engineering, QC/Lab, Document Control, Complaints)
  
  
• Oversee core quality processes such as incoming inspection, product release, nonconformance, and change control
  
  
• Establish and monitor key performance indicators (KPIs) and drive continuous improvement initiatives
  
  
• Exercise authority to halt production or shipments when quality risks are identified

Enterprise QMS Ownership

• Serve as global process owner for the Quality Management System across all sites
  
  
• Maintain and improve the Quality Manual, policies, and core procedures
  
  
• Ensure compliance with applicable regulatory standards (ISO 13485, FDA 21 CFR 820/QMSR, EU MDR)
  
  
• Lead internal audit programs and ensure readiness for external audits (FDA, notified bodies, MDSAP)
  
  
• Facilitate CAPA governance and management review processes
  
  
• Promote a risk-based, data-driven approach to quality and continuous improvement

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline
  
  
• 10-15+ years of progressive experience in Quality within a regulated industry (medical devices preferred; pharma/biotech considered)
  
  
• At least 5 years of direct responsibility for QMS leadership or ownership
  
  
• Demonstrated experience building and maintaining ISO 13485-compliant QMS in multi-site environments
  
  
• Strong track record leading audits and managing regulatory inspections and responses
  
  
• Experience with electronic QMS or document management systems preferred

Preferred Certifications

• ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
  
  
• ISO 13485/9001 Lead Auditor
  
  
• Lean or Six Sigma certification

Additional

• Ability to travel (~15%)
  
  
• Multilingual skills (e.g., French) are a plus

Compensation & Benefits

• Salary range: $130,000 - $150,000
  
  
• Comprehensive medical, dental, and vision coverage
  
  
• 401(k) with employer match
  
  
• Life and AD&D insurance
  
  
• Generous paid time off and holiday schedule
  
  
• Parental leave benefits