Director, Quality Management

EPM Scientific; Monroe (NC); On-site; USD 170,000 - 210,000; Full time

Job summary

EPM Scientific is seeking a Director of Quality Management at a major medical device manufacturer in the Greater Charlotte, NC area. This senior leader will drive site-wide quality operations, oversee multiple quality functions, and ensure regulatory compliance in a highly regulated manufacturing environment.

The role emphasizes CAPA, continuous improvement, and cross-functional collaboration with Operations, Engineering, Manufacturing, Supply Chain, and Regulatory Affairs to deliver product

Qualifications

• 10+ years of progressive Quality leadership experience in medical devices or diagnostics.
• Strong knowledge of FDA regulations, ISO 13485, and cGMP.
• Proven ability to lead multiple quality functions (Engineering, Systems, Control, Release, Compliance).
• Experience driving CAPA, deviation, nonconformance, and continuous improvement.

Responsibilities

• Lead and develop Quality teams across Quality Engineering, Quality Control, Product Release, Complaint Handling & Investigations, and QMS.
• Own the effectiveness and continual improvement of the site's Quality Management System.
• Drive quality metrics, KPI reporting, Management Review activities, and quality performance initiatives.
• Ensure FDA/ISO compliance, cGMP, and internal quality processes.
• Serve as primary quality representative during audits, inspections, and customer interactions.

Skills

Quality Leadership

Regulatory Compliance

CAPA & Investigations

QMS Management

Cross-functional Leadership

Auditing & Inspections

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

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