Director, Quality Systems

ASP Global; Austell (GA); On-site; USD 130,000 - 195,000; 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 functions for Class I/II medical devices sold in the U.S. You will maintain the QMS, manage eQMS (ComplianceQuest), and drive regulatory compliance with ISO 13485 and FDA requirements.

The ideal candidate will bring 10+ years of medical device quality experience, strong leadership, and a proven track record in risk management (ISO 14971), supplier

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years in medical device quality with leadership experience.
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971.
• Experience with internal and supplier audits.
• Proficiency with electronic QMS platforms; ComplianceQuest a plus.
• Demonstrated ability to lead cross-functional teams.

Responsibilities

• Lead the development, implementation, and continuous improvement of the QMS in line with ISO 13485 and FDA regulations.
• Oversee administration and optimization of ComplianceQuest and ensure system integrity.
• Lead external audits including customer, FDA, and Notified Body readiness.
• Manage quality engineering for sustaining activities on medical devices and support design controls.
• Drive CAPA and risk management (ISO 14971) across product lifecycles.
• Develop supplier quality processes and conduct supplier audits.

Skills

Leadership

QMS Oversight

Regulatory Compliance

Risk Management

Audits

Quality Systems

eQMS ComplianceQuest

Cross-Functional Leadership

Education

Bachelor’s in Engineering or Life Sciences

Tools

ComplianceQuest

Job description

Position Summary

We are seeking a strategic and hands-on Director of Quality Systems and Quality Engineering to lead and evolve our quality systems and engineering functions. This role will maintain the quality management system, oversee sustaining engineering for Class I medical devices primarily marketed in the U.S., support new product development initiatives, and manage our electronic Quality Management System (eQMS), ComplianceQuest. The ideal candidate will bring deep expertise in ISO 13485, risk management, supplier quality, audits, and preferably MDSAP, with a strong track record of leadership and cross-functional collaboration.

Key Responsibilities Quality Systems Oversight

• 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), ensuring system integrity, user adoption, and compliance.
• Ensure readiness and lead external audits, including customer, FDA, and Notified Body.
• Conduct quality due diligence for Mergers & Acquisitions.

Quality Engineering Leadership

• 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.

Supplier Quality Management

• 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.

Risk Management & Compliance

• 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.

Leadership & Collaboration

• 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.

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience 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.