Quality Management System Manager

Quality Management System Manager at BioTalent Quality Management System Manager at BioTalent in Oak Park, California Posted in 1 day ago.

Type:

full-time

Job Description:

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