Director of Quality and Regulatory Compliance

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. This includes full responsibility for the company’s Quality Management System (QMS), oversight of all customer and regulatory audits, and direct management of each site’s quality organization, including ITAR compliance, ISO9000 and AS9100 and defense manufacturing requirements and standards. This role will report to the VP of Operations.

This role plays a critical part in ensuring that Lex Innovation’s power distribution assemblies, connectors, and cable systems for industrial, entertainment, and defense applications — consistently meet or exceed ISO 9001, AS9100, UL, NEMA, and MIL-STD, ITAR, and DOD requirements. The Director of Quality will drive alignment, build strong site-level teams, and strengthen Lex’s reputation for safety, reliability, and compliance in both commercial and military markets. 

Essential Duties and Responsibilities:

To perform this role successfully, the individual must be able to perform each essential function at a high level:

• Leadership & Organization Management

o Directly manage and develop Quality Managers, Engineers, and Inspectors across all three sites.

o Define and cascade key performance metrics for product quality, process compliance, and audit readiness.

o Standardize processes and expectations across sites while allowing for flexibility in product-specific needs.

o Act as Lex’s senior quality representative in executive reviews, customer meetings, and external audits.

o Collaborate closely with Operations, Engineering, and Supply Chain to embed quality ownership into daily operations.

• Quality Systems & Compliance

o Lead company-wide compliance with ISO 9001:2015, AS9100, ITAR and applicable MIL-STD regulatory requirements. 

o Maintain certification status, coordinate external audits, and ensure timely completion of corrective and preventive actions (CAPA).

o Oversee product and process documentation, calibration, non-conformance management, and risk-based thinking throughout the QMS.

o Create Standard Operating Procedures for ITAR, ISO9001 and AS9100 as well as direct creation of the same for other managers and leaders. 

o Ensure adherence to UL, NEMA, ETL, and MIL-SPEC product standards — including labeling, packaging, and testing compliance.

o Maintain detailed, audit-ready records of all ISO 9001:2015, AS9100, ITAR and applicable MIL-STD activities, including authorizations, transfers, and training.

o Lead the internal audit program and drive continuous improvement within all facets of the QMS.

o Classifying and tagging USML Controlled parts and assemblies; Controlling technical data, restricted access for authorized personnel only.  

o Coordinating with legal/export control teams for license requirements and approvals.

o Responding to audits and providing evidence of compliance. 

• Customer & Supplier Quality

o Serve as the senior point of contact for customer quality issues, audits, and corrective actions.

o Oversee root cause analysis, containment, and preventive measures for customer returns and field issues.

o Manage supplier qualification, audits, and ongoing performance to ensure incoming materials meet Lex’s standards.

o Collaborate with Engineering and Purchasing to integrate supplier performance data into sourcing and design decisions.

o Advise managers and other members of Lex Innovations on screening suppliers, subcontractors, and visitors against DDTC’s restricted party lists to prevent unauthorized access

• Continuous Improvement

o Establish and track metrics such as FPY, DPPM, COPQ, and Cpk to monitor performance and identify trends.

o Partner with CI and Operations teams to reduce variation, improve process capability, and enhance yield.

o Champion error-proofing, data-driven decision making, and digital quality tools to support Industry 4.0 transformation.

o Promote a proactive culture that emphasizes prevention, documentation, and learning from failures.

• Team Development & Culture

o Build a high-performing quality organization through clear structure, coaching, and professional development.

o Define expectations for leadership, accountability, and communication within each site team.

o Foster a culture of ownership, transparency, and continuous improvement at all levels.

o Model Lex’s core values of integrity, collaboration, and excellence in execution.

o Provide regular ITAR, ISO9001 and AS9100 and export control training for all employees, especially those handling controlled items or data.

• Perform other duties as assigned by supervision to support the success of the operation.

 Knowledge, Skills, Abilities and 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.

 Benefits:

• 401(k)

• 401(k) matching

• Dental insurance

• Disability insurance

• Flexible spending account

• Health insurance

• Life insurance

• Paid time Off

• Vision insurance