Director, Quality Management
Director of Quality Management
A leading global medical device and diagnostics manufacturer is seeking a Director of Quality Management to lead site-wide quality operations and drive the continued evolution of a robust Quality Management System within a highly regulated manufacturing environment.
This individual will serve as the senior quality leader for the site, overseeing multiple quality functions while partnering closely with Operations, Engineering, Manufacturing, Supply Chain, and Regulatory Affairs to ensure product quality, regulatory compliance, and continuous improvement.
Key Responsibilities:
Lead and develop Quality teams across:
- Quality Engineering
- Quality Control
- Product Release
- Complaint Handling & Investigations
- Quality Management Systems (QMS)
Own the effectiveness and continuous improvement of the site's Quality Management System
Drive quality metrics, KPI reporting, Management Review activities, and quality performance initiatives
Ensure compliance with FDA regulations, ISO standards, cGMP requirements, and internal quality processes
Lead CAPA, nonconformance, deviation, and continuous improvement programs
Partner cross-functionally to support manufacturing operations, product quality, and customer satisfaction
Serve as the site's primary quality representative during audits, inspections, and customer interactions
Support global quality initiatives and quality system harmonization efforts across the broader organization
Establish strong quality culture and accountability throughout the manufacturing site
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
10+ years of progressive Quality leadership experience within the medical device industry
Strong knowledge of FDA regulations, ISO 13485, cGMP requirements, and quality systems management
Proven experience leading quality teams within a regulated manufacturing environment
Experience overseeing multiple quality functions, including Quality Engineering, Quality Systems, Quality Control, Product Release, and Compliance activities
Demonstrated success driving continuous improvement and operational excellence initiatives
Strong leadership, communication, and stakeholder management skills
Ability to influence across multiple functions and organizational levels
Preferred Qualifications:
Experience within the in vitro diagnostics (IVD) industry
Experience supporting global quality organizations and multi-site operations
Background leading quality transformation, quality system improvements, or remediation initiatives
Prior responsibility for regulatory inspections and customer audits
Why Consider This Opportunity?
Senior leadership role with broad ownership across site quality operations
Opportunity to lead Quality Engineering, Quality Systems, Product Release, Complaints, and Quality Control functions
High visibility position with significant influence on business performance and quality strategy
Global organization with a strong reputation in the medical device and diagnostics industry
Opportunity to drive meaningful quality improvements and shape the long-term direction of the quality organization
Collaborative culture with executive-level exposure and cross-functional leadership responsibility
Location: Greater Charlotte, North Carolina Area
Industry: Medical Device / Diagnostics
Travel: Approximately 10% Travel Required
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