Director of Quality & Regulatory Compliance

LEX Innovations; Shelton (CT); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Disability insurance

Flexible spending account

Health insurance

Life insurance

Paid time Off

Vision insurance

Job summary

Lex Innovations is seeking a Director of Quality and Regulatory Compliance to lead quality management across three U.S. manufacturing sites, ensuring ISO 9001, AS9100, UL, NEMA, MIL-STD, and ITAR compliance.

The role reports to the VP of Operations and drives continuous improvement in product quality and regulatory readiness. You will manage Quality Managers, engineers, and inspectors, coordinate external audits, and oversee CAPA processes while collaborating with Operations, Engineering, and

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field; Master’s preferred.
• Minimum 10 years of progressive quality management experience with multi-site supervision.
• Deep understanding of ISO 9001:2015, AS9100, ITAR, MIL-STD, UL, and NEMA compliance.

Responsibilities

• Directly manage and develop Quality Managers, Engineers, and Inspectors across all three sites.
• Lead company-wide compliance with ISO 9001:2015, AS9100, ITAR and MIL-STD requirements.
• Serve as senior quality liaison for audits, CAPA, and supplier qualification.

Skills

Leadership

Quality management

ISO 9001:2015

AS9100

ITAR compliance

Audits & CAPA

Process improvement

Data-driven decisions

Cross-site collaboration

Six Sigma / ASQ

Education

Bachelor's degree in Engineering/Quality

Master’s preferred

Job description

Lex Innovations is seeking a Director of Quality and Regulatory Compliance to lead quality management across three U.S. manufacturing sites, ensuring ISO 9001, AS9100, UL, NEMA, MIL-STD, and ITAR compliance.

The role reports to the VP of Operations and drives continuous improvement in product quality and regulatory readiness. You will manage Quality Managers, engineers, and inspectors, coordinate external audits, and oversee CAPA processes while collaborating with Operations, Engineering, and