Manager, Quality Systems

Overview

Manager, Quality Systems at Stratasys Direct Manufacturing (SDM) leads and maintains the Quality Management System to ensure product conformity, regulatory compliance, and customer satisfaction. This role oversees quality inspection and testing, drives continuous improvement, and serves as a key quality liaison with customers, certification bodies, and internal teams to ensure strong quality performance and risk management.

• Ensure QMS processes are established, implemented, maintained, and effective
• Maintain compliance with AS and ISO certifications
• Plan, conduct, and document internal audits
• Coordinate and oversee third-party certification and surveillance audits
• Lead and support customer quality system audits
• Promote awareness of customer and regulatory requirements throughout the organization
• Responsible for leadership, guidance, and professional support of quality inspectors and personnel to achieve functional objectives
• Forecast and plan staffing to meet business needs
• Control departmental costs through productivity optimization, process improvements, and automation
• Develop, maintain, and update customer- and part-specific Quality Work Instructions
• Oversee, in-process, and final inspection activities to ensure product conformity and accuracy
• Report QMS performance, trends, and improvement opportunities to top management
• Enforce company quality standards focused on compliance, accuracy, and on-time delivery
• Drive customer satisfaction initiatives
• Collaborate with Fulfillment Services to manage customer corrective action requests
• Monitor and improve delivery performance and product conformity
• Manage Nonconformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs), ensuring timely closure and effectiveness verification
• Drive cost-of-quality reduction initiatives
• Research and implement quality tools, methodologies, and process improvements
• Assess operational and quality risks and implement practical solutions
• Partner with Operations to enhance quality, efficiency, and customer satisfaction
• Perform contract, blueprint, and drawing reviews
• Provide inspection lead-time estimates and technical input during quoting and planning
• Develop and deliver training for Quality personnel on procedures, equipment, and inspection methods
• Partner with Operations leadership to train employees on quality processes and best practice

As a part of Stratasys, this position requires access to information and/or technology controlled under the International Traffic in Arm s Regulations (ITAR) or the Export Administration Regulations (EAR). The successful candidate must be a U.S. Citizen, lawful permanent resident of the U.S. (or, green card holder), a protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

• High School Diploma or equivalent
• Minimum seven years combined experience in quality control, management, and manufacturing operations
• In depth knowledge of quality control for manufacturing, ISO 9001 & AS9100 quality systems
• Experience leading internal audits and supporting third-party certification audits
• Demonstrated experience managing NCRs and CAPAs
• Ability to interpret contracts, technical drawings, and specification using GD&T
• Experience supervising or leading quality or inspection personnel
• Computer proficiency with MS Windows, MS Office and SPC software
• Excellent written & verbal skills including the ability to read and write specifications & procedures

• Knowledge of ISO 13485
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certification
• Experience in aerospace, defense, or other highly regulated industries
• Experience serving as a Management Representative or primary QMS owner
• Lean Six Sigma Green Belt or Black Belt certification

10%, domestic travel

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