Quality Management System (QMS) Engineer

Aequor; Charlotte (NC); On-site; USD 90,000 - 110,000; Full time

Job summary

Aequor is seeking a QMS Engineer to maintain and improve the site Quality Management System in a regulated medical device environment, onsite in Charlotte, NC. The role supports CAPA, nonconformance, document control, and audit readiness in alignment with FDA regulations and ISO 13485.

You will collaborate across Operations, Engineering, Manufacturing, and Regulatory teams to drive quality system effectiveness, continuous improvement, and regulatory compliance at a medical injection molding and

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.
• Experience with FDA 21 CFR Part 820 / QMSR and ISO 13485.
• Experience in medical injection molding, plastics manufacturing, or medical device assembly preferred.
• Hands-on experience managing CAPAs, NCRs, internal audits, and document control systems.
• Experience using electronic QMS (eQMS) systems preferred.

Responsibilities

• Maintain and update the site Quality Management System per FDA 21 CFR Part 820 / QMSR and ISO 13485.
• Lead CAPA activities from initiation to verification and closure.
• Manage Nonconformance Reports (NCRs) and quality events; drive corrective actions.
• Oversee document control: SOPs, work instructions, forms, records; ensure revision control.
• Plan and perform internal audits; support external/regulatory audits and responses.
• Support development of quality metrics and KPIs; participate in Management Review.

Skills

Root cause analysis

Problem solving

Technical writing

Quality systems

Cross-functional teamwork

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

eQMS

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

• SOPs
• Work instructions
• Forms
• Specifications
• 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
• Support audit preparation activities and coordinate responses to audit findings.
• Track audit observations through closure and verify effectiveness of corrective actions.
• 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
• 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.