Director of Medical Device Quality Systems & Engineering

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

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