Senior Quality Engineer - CAPA & Supplier Quality

Stratasys Ltd; Eden Prairie (MN); On-site; USD 110,000 - 125,000; Full time

Job summary

Stratasys Ltd. in Eden Prairie, MN seeks a Sr Quality Engineer to provide ongoing quality support to manufacturing, focusing on preventing product variability from impacting performance and customer experience.

You will partner with manufacturing, engineering, production, and suppliers to drive quality and compliance, lead CAPA and improvements, and enable new product introductions. The role requires hands-on quality expertise, strong analytical skills, and the ability to mentor production staff

Qualifications

• Bachelor’s degree in Engineering with 5+ years QA experience
• ITAR qualified
• Experience in regulated environment with ISO 9001/AS9100
• Root Cause Analysis and CAPA leadership
• Lead auditor experience
• Statistical analysis and SPC
• Strong cross-functional communication across teams

Responsibilities

• Ensure compliance with internal SOPs, external standards, and regulatory requirements.
• Lead and support CAPA, risk management, change requests, nonconformances, audit findings, and process improvements.
• Collaborate with engineering, manufacturing, production, and supplier teams to investigate and resolve quality issues.
• Support supplier quality activities, including supplier evaluations, material qualifications, supplier audits and reviews, First Article Inspection, and ongoing performance monitoring.
• Develop, evaluate, and implement inspection and testing protocols for in-process, raw, and finished materials.
• Analyze quality data, identify trends, and recommend corrective actions to improve product quality and manufacturing performance.
• Make product containment recommendations for non-conforming material and ensure quality control analyses are completed.
• Prepare, review, and maintain documentation for inspection procedures, testing methods, records, and SOPs.
• Lead, mentor, and train production staff on quality processes and expectations.
• Support validation, qualification, continuation engineering, and continuous improvement projects.
• Follow all safety policies and demonstrate Stratasys values and behaviors.

Skills

Root Cause Analysis

CAPA leadership

Statistical analysis

Auditing

Cross-functional collaboration

Verbal & written communication

Education

Bachelor’s degree in Engineering

Advanced engineering degree

Job description

Stratasys Ltd. in Eden Prairie, MN seeks a Sr Quality Engineer to provide ongoing quality support to manufacturing, focusing on preventing product variability from impacting performance and customer experience.

You will partner with manufacturing, engineering, production, and suppliers to drive quality and compliance, lead CAPA and improvements, and enable new product introductions. The role requires hands-on quality expertise, strong analytical skills, and the ability to mentor production staff