Quality Systems Manager

Position Title: Quality System Manager Location: Monroe, NC Position Summary The Quality System Manager is responsible for maintaining and improving the site’s Quality Management System (QMS) in compliance with regulatory standards.

This position leads the management of electronic quality systems (eQMS), Corrective and Preventive Action (CAPA) processes, change control activities, and internal audit readiness.

The role plays a key part in driving cross-functional alignment and supporting continuous improvement.

Key Responsibilities Electronic Quality Management System (eQMS)Oversee the implementation and ongoing administration of the electronic QMS platform.Manage document control processes, including review, approval, and periodic revision of controlled procedures and records.Partner with document owners to maintain efficiency and compliance in quality documentation workflows.

CAPA Program OversightLead the CAPA program, ensuring thorough investigations, accurate root cause analysis, and effective corrective actions.Facilitate CAPA Review Board meetings, provide status updates, and report key metrics to senior leadership.Review CAPA effectiveness checks to confirm sustainable resolution of quality issues.

Change ControlManage change control processes to ensure changes are evaluated for risk and implemented in a compliant manner.Provide subject matter expertise and support to departments executing change control activities.

Compliance & Continuous ImprovementEnsure alignment of QMS with FDA (21 CFR Part 820), ISO 13485, and ISO 9001 standards.Identify and implement process improvements to enhance system performance.Deliver training and mentorship on QMS topics, including audits, CAPA, and documentation.

Candidate ProfileBachelor’s degree in Engineering, Life Sciences, or a related discipline (advanced degree preferred).5–8 years of experience in a regulated medical device environment, with deep knowledge of QMS, CAPA, audits, and compliance.Proven track record of implementing and maintaining electronic quality systems; experience with MasterControl is a plus.Strong leadership and project management skills with experience in driving regulatory compliance initiatives.Thorough understanding of FDA and ISO quality system requirements.