Quality Management System Leader

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 ResponsibilitiesSite Quality LeadershipLead all quality activities at the manufacturing site, including both daily operations and long-term strategyManage 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 controlEstablish and monitor key performance indicators (KPIs) and drive continuous improvement initiativesExercise authority to halt production or shipments when quality risks are identifiedEnterprise QMS OwnershipServe as global process owner for the Quality Management System across all sitesMaintain and improve the Quality Manual, policies, and core proceduresEnsure 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 processesPromote a risk-based, data-driven approach to quality and continuous improvementQualificationsBachelor's degree in Engineering, Life Sciences, Quality, or a related discipline10-15+ 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 ownershipDemonstrated experience building and maintaining ISO 13485-compliant QMS in multi-site environmentsStrong track record leading audits and managing regulatory inspections and responsesExperience with electronic QMS or document management systems preferredPreferred CertificationsASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)ISO 13485/9001 Lead AuditorLean or Six Sigma certificationAdditionalAbility to travel (~15%)Multilingual skills (e.g., French) are a plusCompensation & BenefitsSalary range: $130,000 - $150,000Comprehensive medical, dental, and vision coverage401(k) with employer matchLife and AD&D insuranceGenerous paid time off and holiday scheduleParental leave benefits

Created: 2026-05-09