Med Device QA Leader & Regulatory Compliance Champion

Aptyx; Charlotte (NC); On-site; USD 130,000 - 180,000; Full time

Job summary

Aptyx Charlotte is seeking a Quality Assurance Manager to lead the site Quality Assurance and Regulatory Compliance functions, ensuring FDA and ISO 13485 compliance for disposable medical devices and related products. The role partners with R&D, Engineering, Program Management, and Operations to support product development from concept through production and commercialization.

The position leads the Quality team, oversees audits, CAPA, supplier quality, and continuous improvement initiatives to

Qualifications

• Demonstrated leadership and ability to drive results in a dynamic environment.
• Culture of quality, accountability and continuous improvement.
• Mandatory medical device quality experience, including involvement in complex product development and manufacturing projects.
• ISO 13485 Lead Auditor certification or equivalent is preferred.
• Experience with FDA regulations and ISO quality management systems.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead the site's Quality Assurance and Regulatory Compliance functions.
• Maintain and improve the Quality Management System (QMS) to meet FDA and ISO standards.
• Serve as the site Management Representative for quality and regulatory programs.
• Oversee supplier quality, product quality, audit readiness, CAPA, MRB, and risk management.
• Partner with R&D, Engineering, and Operations on product development and transfer to production.
• Drive continuous improvement and establish KPIs for quality performance.

Job description

Aptyx Charlotte is seeking a Quality Assurance Manager to lead the site Quality Assurance and Regulatory Compliance functions, ensuring FDA and ISO 13485 compliance for disposable medical devices and related products. The role partners with R&D, Engineering, Program Management, and Operations to support product development from concept through production and commercialization.

The position leads the Quality team, oversees audits, CAPA, supplier quality, and continuous improvement initiatives to