Quality Director

Overview:

We are seeking an experienced Quality Director to lead and manage the quality organization at our Westborough facility. The Quality Director will develop and implement quality policies, oversee ISO certifications, support regulatory compliance, and drive continuous improvement initiatives across the organization.

Key Responsibilities:

Manage the overall quality function, including policies, objectives, and metrics. Lead quality improvement efforts and ensure compliance with

ISO 9001, ISO

13485, AS9100, and

ISO14001

standards. Chair MRB and disposition nonconforming products. Oversee calibration systems, preventive maintenance programs, and supplier quality assurance. Train staff on accept/reject criteria, workmanship standards, and regulatory requirements. Support corporate and site 6S and Lean initiatives. Implement new processes to improve throughput and reduce defects. Ensure awareness of regulatory and customer requirements throughout the organization. Collaborate with cross-functional teams on continuous improvement and operational excellence.

Qualifications:

Bachelor's degree in Engineering or related discipline. Minimum 10 years of experience in quality management within a manufacturing environment. Proven ability to manage large teams and multiple technical projects simultaneously. Knowledge of IPC standards, PC-A-610, IPC-DVD-64C, FDA regulations, ITAR compliance, and World Class Manufacturing practices. Strong analytical, strategic thinking, and problem-solving skills. Proficiency in Microsoft Office Suite. Excellent communication, presentation, and leadership skills. Must be a U.S. Citizen due to

ITAR/CUI

compliance.

Benefits:

Comprehensive medical, dental, and vision coverage Company-paid life/AD&D insurance, short-term and long-term disability Voluntary supplemental insurances and flexible spending accounts Paid vacation, sick leave, and company holidays 401(k) Retirement Savings Plan with company match Employee Assistance Program (EAP)

Other Requirements:

Must pass a pre-employment background check and drug test (including screening for illegal drugs and marijuana). Commitment to maintaining a safe and productive work environment. #

KPB Pay:

$120,000.00 - $140,000.00 per year

Work Location:

In person