Quality Systems Engineer II — QMS, CAPA & Audit Lead

Artivion, Inc.; Kennesaw (GA); On-site; USD 85,000 - 120,000; Full time

Job summary

Artivion, Inc. in the Atlanta area is seeking a Quality Systems professional to lead the QMS across the company. You will oversee CAPA, audit programs, change control, and training to ensure regulatory compliance and continuous improvement.

Responsibilities include maintaining the QMS, coordinating internal and external audits, driving CAPA closure, performing gap analyses against ISO and GMP standards, and supporting eQMS initiatives. Strong analytical and communication skills are essential.

Qualifications

• Bachelor’s degree in a technical/scientific field or equivalent years of experience.
• 3+ years in quality engineering/quality assurance or similar role.
• ASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferred.
• Experience with electronic quality management systems and QA software tools.
• Working knowledge of GMP, ISO standards and related regulations.

Responsibilities

• Oversee effective implementation and maintenance of the Quality Management System (QMS).
• Coordinate corrective actions, preventive actions and root cause analysis.
• Support internal audits and manage external assessments.
• Provide training related to QMS, CAPA, and audit programs.
• Assist management review, nonconformance oversight, and change control.
• Administer and improve the eQMS software systems.
• Report KPIs and contribute to continuous quality improvements.
• Monitor CAPAs to ensure timely closure and effectiveness.

Skills

Analytical skills

Problem solving

Verbal & written communication

Quality system oversight

Audit coordination

Education

Bachelor's degree in technical/scientific field

Tools

QA software tools

Electronic QMS

Job description

Artivion, Inc. in the Atlanta area is seeking a Quality Systems professional to lead the QMS across the company. You will oversee CAPA, audit programs, change control, and training to ensure regulatory compliance and continuous improvement.

Responsibilities include maintaining the QMS, coordinating internal and external audits, driving CAPA closure, performing gap analyses against ISO and GMP standards, and supporting eQMS initiatives. Strong analytical and communication skills are essential.