Sr Quality Systems Engineer

Stratasys is a world leader in 3D printing. It leads the global shift to additive manufacturing with innovative solutions for aerospace, automotive, consumer products, and healthcare. Through smart, connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys delivers competitive advantages across the product value chain. The Senior Quality Systems Engineer will support a company‑wide quality transformation, ensuring that customer and regulatory requirements for manufacturing readiness are met. The role focuses on developing, implementing, and continuously improving quality standards, procedures, and processes that support business goals and customer expectations. Responsibilities QMS System and Continuous Improvement Lead development and improvement of company‑wide programs and systems to support the quality transformation (e.g., counterfeit prevention, QMS certifications, business continuity, root cause and corrective action analysis, risk‑based thinking, data‑driven decision making, and industry best practices). Work with cross‑functional teams to develop and implement customer‑driven specification compliance. Serve as the subject‑matter expert on RCCA and CAPAs; coach and mentor the organization to sustain growth. Stay updated on industry best practices, emerging quality trends, and regulatory changes. Audits and Assessments Conduct internal and external quality system, process, and product audits to ensure compliance with business requirements and quality standards. Ensure adherence to ISO 9001, AS 9100, ISO 13485, and other industry‑specific regulations. Oversee scheduling, coordination, and execution of audits. Lead risk‑management activities, including the development of FMEAs, process control plans, and quality agreements. Monitor & Measure Develop, optimize, and sustain metrics that manage QMS processes for compliance and health. Apply statistical techniques and Six Sigma tools to analyze processes and drive continuous improvement. Support development, approval, and execution of process validation protocols and reports for critical processes. Analyze quality data to identify trends and present findings and recommendations to management and stakeholders. Travel required: None. Qualifications Basic Export Control Compliance (ITAR) required. Strong knowledge of ISO 9001 and exposure to AS 9100. Five years’ experience in a manufacturing or quality assurance organization, using data for decision making. Proficiency in Lean methodologies and a Six Sigma green‑belt certification. Excellent statistical/analytical skills with experience in SPC techniques and the ability to coach others. Solid understanding of corrective and preventive actions, root cause analysis, FMEA, and nonconforming material control. Good engineering practices, including documentation, engineering change control, reporting, and cost/benefit analysis. Preferred Knowledge of counterfeit program requirements. Project Management Professional (PMP) or equivalent certification. Certified Quality Engineer and/or Certified Quality Auditor (ASQ). Knowledge of ISO 13485 and/or FDA Quality Management System Regulation. Knowledge of EU Medical Device Regulation (MDR) and FDA QMSR. Benefits Competitive salary range: $110,000–$125,000 base (variable incentive pay not included). Comprehensive total rewards program that supports a people‑first strategy. Access to benefits and perks for you and your family. Stratasys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin, or any other characteristic protected under federal, state, or applicable local law. #J-18808-Ljbffr Stratasys