Director, Quality Systems at ASP Global, LLC

Austell, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Feb, 26

Salary

0.0

Posted On

24 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 13485, FDA Regulations, Electronic QMS, ComplianceQuest, Audits, Risk Management, Supplier Quality, Leadership, Cross-Functional Collaboration, Root Cause Analysis, Corrective Actions, New Product Development, Engineering Support, Continuous Improvement, Team Building

Industry

Description

Job Details Job Location: AUSTELL, GA Position Type: Full Time Education Level: 4 Year Degree Salary Range: Undisclosed Travel Percentage: None Job Category: QA - Quality Control 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. Master’s degree or advanced certification (e.g., ASQ CQE, CQA). Experience with MDSAP audit preparation and execution. Background in Class I and II medical devices and sustaining engineering. Experience supporting new product development quality activities. Familiarity with global regulatory requirements and standards.

Responsibilities

The Director of Quality Systems will lead the development and continuous improvement of the Quality Management System while overseeing quality engineering for medical devices. This role includes managing external audits and ensuring compliance with applicable standards and regulations.