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ASP Global · 1 month ago

Director, Quality Systems (60715)

AUSTELL, GA, USA

Full-time

Onsite

Director/Executive

10+ years exp

ASP Global is seeking a strategic and hands-on Director of Quality Systems and Quality Engineering to lead and evolve their quality systems and engineering functions. This role involves maintaining the quality management system, overseeing sustaining engineering for Class I medical devices, and managing the electronic Quality Management System (eQMS). The ideal candidate should have expertise in ISO 13485 and risk management, along with a strong leadership background.

Medical

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), 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

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

Qualification

ISO 13485Quality Management SystemSupplier Quality ManagementRisk ManagementComplianceQuestLeadershipCross-functional CollaborationInternal AuditsMDSAPClass III DevicesNew Product DevelopmentGlobal Regulatory RequirementsCommunicationStrategic ThinkingProblem-solving