Quality Systems Manager – ISO/AS9100 & Audit Lead

Stratasys Ltd; Minnetonka (MN); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental & Vision

401(k) with company match

Employee stock purchase plan

Job summary

Stratasys Direct Manufacturing seeks a Manager, Quality Systems to lead the Quality Management System, ensuring product conformity, regulatory compliance, and customer satisfaction. You will oversee inspections, testing, and continuous improvement while collaborating with customers and internal teams to manage risks.

The role requires directing audits, maintaining certifications, and driving cost-effective quality improvements across manufacturing operations. Travel may be involved as needed.

Qualifications

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

Responsibilities

• Establish, implement, maintain, and monitor QMS processes.
• Ensure 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 across the organization.
• Provide leadership and mentorship to quality inspectors and staff.
• Forecast staffing and manage departmental costs through process improvements.

Skills

QMS leadership

Audits & compliance

NCRs & CAPAs

GD&T interpretation

Supervising quality staff

MS Windows/MS Office

Verbal & written communication

Education

High School Diploma or equivalent

Job description

Stratasys Direct Manufacturing seeks a Manager, Quality Systems to lead the Quality Management System, ensuring product conformity, regulatory compliance, and customer satisfaction. You will oversee inspections, testing, and continuous improvement while collaborating with customers and internal teams to manage risks.

The role requires directing audits, maintaining certifications, and driving cost-effective quality improvements across manufacturing operations. Travel may be involved as needed.