Director of Quality & Compliance

Work Location: Waltham, MA

Summary:

Seeking an experienced quality leader to oversee compliance efforts and drive the implementation and continuous improvement of a robust Quality Management System (QMS) across all products and services. This role will lead a quality team, ensure alignment with regulatory standards, and support effective product development, manufacturing, and fulfillment throughout the product lifecycle.

Responsibilities:

• Provide subject matter expertise on quality and compliance standards, ensuring alignment with evolving program and customer requirements.
• Lead the definition, implementation, and governance of QMS elements, including management reviews, audits, CAPA, document control, and training systems.
• Oversee the integration of QMS with organizational structure, policies, and enterprise solutions such as Document Management, CRM, ERP, and MES.
• Monitor and report on product and system performance, trends, and risks to executive leadership, utilizing KPIs and health metrics to drive improvements.
• Direct the development and maintenance of product and part-specific quality plans, supporting both defense and commercial programs.
• Lead investigations into significant quality issues, collaborating with cross-functional teams to identify root causes and implement corrective actions.
• Manage supplier quality systems to ensure alignment with internal QMS expectations and facilitate robust purchasing and supplier oversight programs.
• Educate and train employees on QMS responsibilities, facilitate risk assessments, and ensure timely completion of audit reports and corrective actions using industry-standard techniques.

Qualifications:

• 10+ years of experience in Quality Management, with emphasis on defense industry requirements within a manufacturing environment.
• BA/BS degree in Engineering or Business required; advanced degree strongly preferred.
• Experience leading ISO certification processes from gap analysis through certification.
• In-depth knowledge of regulations and guidelines relevant to defense and manufacturing sectors.
• Proven experience designing, implementing, or transforming enterprise QMS frameworks.
• Experience managing, hosting, and supporting customer audits and defense agency inspections.
• Strong understanding of New Product Introduction process deliverables and stages.
• Demonstrated leadership skills and experience managing quality teams.
• Excellent communication and interpersonal skills for effective cross-functional and external collaboration.
• Strong problem-solving and decision-making abilities with a continuous improvement mindset.
• Relevant certifications are desirable.

Published Category: Quality & Validation