About this opportunity
Aequor lists this Quality Management System (Qms) Engineer opportunity in charlotte, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Quality Management System (QMS) Engineer
Onsite in Charlotte, NC
Full-Time
The Quality Management Systems (QMS) Engineer is responsible for maintaining, improving, and ensuring compliance of the Quality Management System (QMS) within a regulated medical device manufacturing environment. This role supports quality system processes including CAPA, nonconformance management, document control, internal auditing, and external regulatory and customer audits while ensuring compliance with FDA regulations, ISO 13485, and applicable customer requirements.
The QMS Engineer partners cross-functionally with Operations, Engineering, Manufacturing, Quality, Supply Chain, and Regulatory teams to drive quality system effectiveness, continuous improvement, and regulatory compliance across a medical injection molding and assembly manufacturing facility.
Essential Duties and Responsibilities
Quality Management System Administration
Maintain and improve the site Quality Management System in accordance with:
FDA 21 CFR Part 820 / QMSR requirements
ISO 13485
Applicable customer and regulatory requirements
Internal corporate quality standards
Support development, implementation, revision, and maintenance of quality procedures, work instructions, forms, and records.
Ensure QMS documentation remains current, controlled, and compliant.
CAPA Management
Lead and coordinate Corrective and Preventive Action (CAPA) activities from initiation through effectiveness verification and closure.
Facilitate root cause investigations using structured problem-solving methodologies such as:
5 Why
Fishbone/Ishikawa
Fault Tree Analysis
Risk-based approaches
Ensure timely completion of action items and maintain compliance to CAPA metrics and timelines.
Monitor CAPA trends and identify systemic improvement opportunities.
Nonconformance & Quality Event Management
Manage Nonconformance Reports (NCRs) and related quality events.
Support investigation, containment, disposition, and resolution activities for nonconforming material and product.
Collaborate with Manufacturing Engineering, Production, and Quality teams to determine appropriate corrective actions.
Analyze quality data and trends to drive continuous improvement initiatives.
Document Control
Administer document control processes including:
SOPs
Work instructions
Forms
Specifications
Validation documentation
Quality records
Ensure proper revision control, approval routing, archival, and retention practices.
Support training compliance activities associated with document revisions and implementation.
Audits & Regulatory Compliance
Plan, schedule, and perform internal quality system audits.
Participate in external audits including:
FDA inspections
ISO registrar audits
Customer audits
Supplier audits
Support audit preparation activities and coordinate responses to audit findings.
Track audit observations through closure and verify effectiveness of corrective actions.
Continuous Improvement
Support continuous improvement initiatives focused on quality system effectiveness and compliance.
Assist in development and monitoring of quality metrics and KPIs.
Participate in Management Review activities and preparation of supporting quality data.
Promote a culture of compliance, accountability, and continuous improvement throughout the organization.
Qualifications
Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline preferred.
Minimum 3–5 years of Quality Systems experience in a regulated medical device manufacturing environment.
Strong working knowledge of:
FDA 21 CFR Part 820 / QMSR
ISO 13485
Risk management principles
Medical device quality system requirements
Experience within medical injection molding, plastics manufacturing, or medical device assembly preferred.
Hands-on experience managing:
CAPAs
NCRs
Internal audits
Document control systems
Regulatory and customer audits
Experience using electronic QMS systems (eQMS) preferred.
Strong root cause analysis and problem-solving skills.
Excellent organizational, communication, and technical writing skills.
Ability to manage multiple priorities in a fast-paced manufacturing environment.
Preferred Certifications
ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification preferred.
ISO 13485 Internal Auditor or Lead Auditor certification preferred.
Worksite address
charlotte, NC, 28245, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.