Sr Quality Engineer

Sr Quality EngineerLocation: Eden Prairie, MN, USCategory: Manufacturing & OperationsStratasys 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.Position DescriptionStratasys 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 QualificationsBachelor'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 QualificationsProficient 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.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 base salary range will be added once confirmed. This range will represent a good faith estimate for this position. Individual base pay will depend on skills, qualifications, geographical location, and/or experience.