Sr Quality Engineer

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

Sr Quality Engineer

Job ID: 55438 Category: Manufacturing & Operations

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

Location

Eden Prairie, MN

Position Description

Stratasys is seeking a Quality Engineer to provide ongoing quality support to manufacturing with a focus on preventing product variability from impacting product performance and customer experience. In this role, you will partner cross-functionally with manufacturing, engineering, production, and supplier teams to drive quality performance, support new product introduction, lead corrective and preventive actions, and ensure compliance with internal procedures and external standards.

This is an opportunity for a hands‑on quality professional who enjoys solving complex manufacturing challenges, strengthening supplier quality performance, and helping build processes that support reliable, high‑quality products for customers.

Essential Duties and Responsibilities include the following:

• Assure compliance with internal SOPs, external standards, and applicable regulatory requirements.
• Lead and support CAPA, risk management, change requests, nonconformances, audit findings, and process improvement initiatives.
• Collaborate with engineering, manufacturing, production, and supplier teams to investigate and resolve quality and compliance issues.
• Support supplier quality activities, including supplier evaluations, material qualifications, supplier audits and reviews, First Article Inspection, ongoing performance monitoring, and supplier issue resolution.
• Develop, evaluate, and implement inspection and testing protocols for in-process materials, raw materials, and finished products.
• 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 appropriate quality control analysis is completed.
• Prepare, review, and maintain documentation for inspection procedures, testing methods, records, and SOPs.
• Lead, mentor, and train production staff and technicians on quality processes and expectations.
• Support validation, qualification, continuation engineering, and continuous improvement projects.
• Follow all company safety policies and procedures, complete required training, and demonstrate commitment to Stratasys values and behaviors.

Basic Qualifications

• Bachelor’s degree in Engineering and 5+ years of applicable Quality Engineering experience in a related field, or an advanced degree.
• In lieu of degree, 6+ years of applicable Engineering or Quality Engineering work experience.
• Must be ITAR qualified.
• Experience working in a regulated environment with knowledge of ISO 9001 and AS9100.
• Proficient knowledge of Root Cause Analysis, including experience leading CAPA activities.
• Demonstrated experience as a lead auditor.
• Basic statistical analysis skills, including Statistical Process Control.
• Strong verbal and written communication skills with the ability to partner effectively across teams.

Preferred Qualifications

• Proficient statistical and analytical problem‑solving skills, with the ability to teach and coach others.
• Demonstrated ability to lead projects, investigations, and cross‑functional teams.
• Basic knowledge of continuous improvement methodologies and tools, including Six Sigma and Gauge R&R.
• Fundamental experience with PFMEAs and risk management.
• ASQ CQA, CQE, or Six Sigma Black Belt certification preferred.

Travel Required

[Insert travel requirement]

We believe our people are the heart of our success. That’s why we’ve designed a comprehensive Total Rewards program that goes beyond the basics and supports our People First strategy. When you join Stratasys, you’ll gain access to benefits and perks that will support you and your family both inside and outside of work.

For this position, the typical annual starting $110,000-$125,000 This range will represent a good faith estimate for this position. Individual base pay will depend on skills, qualifications, geographical location, and/or experience.

What you will be part:

• Company Overview - https://www.stratasys.com/en/about-us/history/
• Our Culture and Values - https://www.stratasys.com/en/about-us/culture/
• Our Sustainability “3D Printing a Better Tomorrow” - https://www.stratasys.com/en/about-us/sustainability/
• Our Locations - https://www.stratasys.com/en/contact-us/office-locations/
• Check out our Video - https://www.youtube.com/watch?v=6wmDfmt2bNI