Quality Director

Ignite Human Capital•Westborough, MA

3d•$130,000 - $145,000

About The Position

We are seeking a strategic and hands-on Quality Leader to drive enterprise-wide quality excellence across complex manufacturing operations. This role is responsible for shaping quality strategy, leading continuous improvement initiatives, ensuring compliance with critical regulatory and industry standards, and building a culture of operational excellence. The ideal leader brings a balance of executive-level strategic thinking and practical execution, with deep expertise in regulated manufacturing environments, supplier quality, process optimization, and cross-functional leadership. This is an opportunity to make a meaningful impact by elevating quality systems, improving throughput, reducing defects, and strengthening organizational performance across the business.

Requirements

Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
10+ years of progressive quality leadership experience in a regulated manufacturing environment.
Deep experience with electronic manufacturing, aerospace, defense, medical device, or highly regulated production environments.
Strong knowledge of: ISO 9001 / ISO 13485 / AS9100 / ISO 14001
Strong knowledge of: FDA quality and compliance requirements
Strong knowledge of: ITAR regulations
Strong knowledge of: IPC standards (including component identification, workmanship, inspection standards)
Strong knowledge of: CAPA, MRB, supplier quality, calibration systems, and process quality controls
Strong knowledge of: Lean Manufacturing / World Class Manufacturing / continuous improvement methodologies
Proven ability to lead large teams and manage multiple technical initiatives simultaneously.
Strong executive presence, communication skills, and the ability to influence across engineering, manufacturing, operations, and executive leadership.
Strategic thinker with strong analytical problem-solving skills and a bias toward action.
Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen.

Responsibilities

Lead the overall quality function, including quality systems, compliance, reporting, and continuous improvement initiatives.
Serve as the executive quality leader for ISO-certified quality management systems, including ISO 9001, ISO 13485, AS9100, and support environmental management initiatives aligned with ISO 14001.
Act as Management Representative for applicable quality certifications, ensuring audit readiness and ongoing compliance.
Drive enterprise quality planning for products, processes, and manufacturing operations.
Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials.
Establish and monitor quality KPIs, dashboards, and performance metrics to drive measurable improvement.
Lead corrective and preventive action (CAPA) processes in partnership with Engineering, Manufacturing, and Operations.
Partner with suppliers to strengthen supplier quality standards, compliance, and performance.
Oversee calibration systems, preventive maintenance quality controls, and product/process quality assurance programs.
Champion Lean, 6S, and operational excellence initiatives to improve quality, throughput, and efficiency.
Develop and implement quality policies, procedures, and training programs to ensure consistent workmanship and adherence to standards.
Promote awareness of customer, regulatory, and quality requirements throughout the organization.
Ensure compliance with applicable regulatory frameworks including FDA, ITAR, IPC standards, and electronic manufacturing quality requirements.
Lead, mentor, and develop quality teams while influencing cross-functional stakeholders at all levels.