Director, Quality Systems & Medical Devices Engineering

ASP Global; Austell (GA); On-site; USD 150,000 - 190,000; Full time

Job summary

ASP Global in Austell, GA is seeking a strategic and hands-on Director of Quality Systems and Quality Engineering to lead and evolve our quality systems. You will maintain the QMS, oversee sustaining engineering for Class I/II medical devices marketed in the U.S., support new product development, and manage our eQMS (ComplianceQuest).

The ideal candidate has deep ISO 13485, risk management, supplier quality, audits, and leadership experience, with a track record of cross-functional collaboration

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 10+ years in medical device quality with at least 5 years in a leadership role.
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and supplier quality.
• Experience with internal and supplier audits.
• Proficiency with electronic QMS platforms; ComplianceQuest experience is a plus.
• Demonstrated ability to lead teams and drive cross-functional collaboration.
• Excellent communication, leadership, strategic thinking, and problem-solving skills.

Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
• Oversee the administration and optimization of the eQMS platform (ComplianceQuest).
• Ensure readiness and lead external audits, including customer, FDA, and Notified Body.
• Conduct quality due diligence for Mergers & Acquisitions.
• Manage a team of quality engineers supporting sustaining activities for Class I and II medical devices.
• Provide quality engineering support for new product development, including design control, risk management (ISO 14971), and verification/validation activities.
• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.
• Develop and maintain robust supplier quality processes including qualification, monitoring, and auditing.
• Collaborate with Sourcing and Operations to ensure supplier compliance and performance.
• Ensure supplier audits are performed and support resolution of supplier-related quality issues.
• Champion risk-based thinking across the organization, ensuring effective risk management practices are embedded in product lifecycle processes.
• Ensure QMS alignment with applicable standards and regulations.
• Build and mentor a high-performing quality team, fostering a culture of accountability, continuous improvement, and collaboration.
• Partner cross-functionally with R&D, Operations, Regulatory, and Sourcing to ensure quality objectives are met.
• Represent Quality in strategic planning and business reviews.

Skills

Leadership

Cross-functional collaboration

Quality Systems

ISO 13485 knowledge

FDA regulations knowledge

Auditing

CAPA

Risk management

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Master’s degree or advanced certification (ASQ CQE, CQA)

Tools

ComplianceQuest

Job description

ASP Global in Austell, GA is seeking a strategic and hands-on Director of Quality Systems and Quality Engineering to lead and evolve our quality systems. You will maintain the QMS, oversee sustaining engineering for Class I/II medical devices marketed in the U.S., support new product development, and manage our eQMS (ComplianceQuest).

The ideal candidate has deep ISO 13485, risk management, supplier quality, audits, and leadership experience, with a track record of cross-functional collaboration