Quality Systems Manager — QMS, ISO & Audit Leader

Stratasys Ltd; Belton (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Stratasys Direct Manufacturing (SDM) is seeking a Manager, Quality Systems in Belton, TX to lead the Quality Management System, ensuring product conformity, regulatory compliance, and customer satisfaction. The role covers quality inspection, audits, and continuous improvement across the organization.

The ideal candidate will have extensive ISO 9001/AS9100 knowledge, internal audits, NCRs/CAPAs experience, and strong leadership with collaboration across Operations and Fulfillment Services.

Qualifications

• 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

Responsibilities

• Establish, implement, maintain, and improve QMS processes
• Maintain compliance with AS and ISO certifications
• Plan, conduct, and document internal audits
• Coordinate third-party certification and surveillance audits
• Lead and support customer quality system audits
• Promote awareness of customer and regulatory requirements
• Forecast and plan staffing
• Control departmental costs through productivity optimization and automation
• Develop and update Quality Work Instructions
• Oversee inspection activities
• Report QMS performance to top management
• Drive customer satisfaction initiatives
• Collaborate with Fulfillment Services to manage corrective actions
• Monitor and improve delivery performance
• Manage NCRs and CAPAs
• Research and implement quality tools, methodologies

Skills

Quality leadership

Auditing

Regulatory compliance

Contract interpretation

GD&T

Supervising personnel

Communication

Education

High School Diploma or equivalent

ASQ certifications (CQE, CQA, CMQ/OE)

Tools

MS Windows

MS Office

SPC software

Job description

Stratasys Direct Manufacturing (SDM) is seeking a Manager, Quality Systems in Belton, TX to lead the Quality Management System, ensuring product conformity, regulatory compliance, and customer satisfaction. The role covers quality inspection, audits, and continuous improvement across the organization.

The ideal candidate will have extensive ISO 9001/AS9100 knowledge, internal audits, NCRs/CAPAs experience, and strong leadership with collaboration across Operations and Fulfillment Services.