Director of Quality and Regulatory Compliance

About the role

The Director of Quality provides strategic and hands-on leadership for all aspects of product quality, compliance, and continuous improvement across Lex Innovation’s three U.S. manufacturing facilities.

Responsibilities

• Directly manage and develop Quality Managers, Engineers, and Inspectors across all three sites.
• Define and cascade key performance metrics for product quality, process compliance, and audit readiness.
• Standardize processes and expectations across sites while allowing for flexibility in product-specific needs.
• Act as Lex’s senior quality representative in executive reviews, customer meetings, and external audits.
• Collaborate closely with Operations, Engineering, and Supply Chain to embed quality ownership into daily operations.
• Lead company-wide compliance with ISO 9001:2015, AS9100, ITAR and applicable MIL-STD regulatory requirements.
• Maintain certification status, coordinate external audits, and ensure timely completion of corrective and preventive actions (CAPA).
• Oversee product and process documentation, calibration, non-conformance management, and risk-based thinking throughout the QMS.
• Create Standard Operating Procedures for ITAR, ISO9001 and AS9100 as well as direct creation of the same for other managers and leaders.
• Ensure adherence to UL, NEMA, ETL, and MIL-SPEC product standards — including labeling, packaging, and testing compliance.
• Maintain detailed, audit-ready records of all ISO 9001:2015, AS9100, ITAR and applicable MIL-STD activities, including authorizations, transfers, and training.
• Lead the internal audit program and drive continuous improvement within all facets of the QMS.
• Classifying and tagging USML Controlled parts and assemblies; Controlling technical data, restricted access for authorized personnel only.
• Coordinating with legal/export control teams for license requirements and approvals.
• Responding to audits and providing evidence of compliance.
• Serve as the senior point of contact for customer quality issues, audits, and corrective actions.
• Oversee root cause analysis, containment, and preventive measures for customer returns and field issues.
• Manage supplier qualification, audits, and ongoing performance to ensure incoming materials meet Lex’s standards.
• Collaborate with Engineering and Purchasing to integrate supplier performance data into sourcing and design decisions.
• Advise managers and other members of Lex Innovations on screening suppliers, subcontractors, and visitors against DDTC’s restricted party lists to prevent unauthorized access.
• Establish a high-performing quality organization through clear structure, coaching, and professional development.
• Define expectations for leadership, accountability, and communication within each site team.
• Foster a culture of ownership, transparency, and continuous improvement at all levels.
• Model Lex’s core values of integrity, collaboration, and excellence in execution.
• Provide regular ITAR, ISO9001 and AS9100 and export control training for all employees, especially those handling controlled items or data.

Requirements

• 1+ years of experience in material handling, kitting, inventory control, or production support within a manufacturing environment (experience with electrical/mechanical parts preferred).
• Bachelor’s degree in Engineering, Quality, or related field (Master’s preferred).
• Minimum of 10 years of progressive experience in quality management, including direct supervision of multi-site teams.
• Proven track record in manufacturing environments with electrical and power distribution assemblies, wiring systems, or related products — highly preferred.
• Deep understanding of ISO 9001:2015, AS9100, ITAR, MIL-STD, UL, and NEMA compliance frameworks.
• Demonstrated success leading customer audits, managing CAPA systems, and improving process performance.
• Strong analytical, communication, and leadership skills with the ability to influence across functions and sites.
• ASQ certifications (CQE, CQA, CMQ/OE) or Six Sigma certification strongly preferred.
• Travel between manufacturing sites (Shelton CT, Davie FL, Pacoima CA), customers, and vendors between 30 to 50% or as required.