Onsite QMS Engineer - Medical Device Quality & Compliance

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

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