Senior Quality Director, Medical Devices & QMS

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

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