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Sr Quality Systems Engineer

Stratasys

  • Eden Prairie, MN
  • 4 days ago
  • $110,000–$125,000 Per Year

Highlights

ResponsibilitiesQMS System and Continuous ImprovementLead 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. Knowledge of EU Medical Device Regulation (MDR) and FDA QMSR.BenefitsCompetitive salary range: $110,000–$125,000 base (variable incentive pay not included).Comprehensive total rewards program that supports a people‑first strategy.

Numbers & Facts

LocationEden Prairie, MN
IndustryEngineering Services
Salary$110,000–$125,000 Per Year
Company Size2,500 to 4,999 employees
Year Founded1987
Websitehttp://www.stratasys.com/

Description

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.ResponsibilitiesQMS System and Continuous ImprovementLead 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 AssessmentsConduct 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 & MeasureDevelop, 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.QualificationsBasicExport 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.PreferredKnowledge 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.BenefitsCompetitive 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

About Company

OVERVIEW

Stratasys Ltd. was formed in 2012 by the merger of Stratasys Inc. and Objet Ltd. We manufacture 3D printers and materials that create prototypes and manufactured goods directly from 3D CAD files or other 3D content. The 3D printers are based on patented FDM® and PolyJet® inkjet-based technologies.

Stratasys systems are used by manufacturers to create models and prototypes to aid in the new product design process. And they are becoming widely used for production of finished goods in low-volume manufacturing. Systems range from affordable desktop 3D printers to large production systems for direct digital manufacturing.

The FDM process creates parts by extruding molten thermoplastic in fine layers to build the part layer by layer. The PolyJet process also creates parts by building in layers but employs an ink jet style jetting process to apply photopolymers in fine layers and simultaneously cures them with ultraviolet light.

Stratasys also manufacturers Solidscape 3D Printers and operates the RedEye On Demand digital manufacturing service. We have over 1000 employees and hold over 500 granted or pending additive manufacturing patents globally. Our range of 120 3D printing materials is the widest in the industry and includes over 100 proprietary inkjet-based photopolymer materials and 10 proprietary FDM-based thermoplastic materials.

Through our network of certified, value added resellers and distributors, Stratasys delivers responsive, regional support around the globe. Stratasys maintains dual headquarters in Minneapolis, Minnesota and Rehovot, Israel. Stratasys is a public company that trades on the NASDAQ stock exchange under the symbol SSYS.

OUR TECHNOLGIES

Our 3D printing technologies are additive manufacturing at its best.

Fused Deposition Modeling (FDM®)
Prototypes, tools and production parts made with FDM Technology are tough enough to not only test functionality, but hold up under everyday use. Uniquely, FDM uses real thermoplastics like ABS, polycarbonate and ULTEM 9085. The ability to print in these end-use manufacturing materials is the main reason FDM is a highly sought-after 3D printing technology.

PolyJet®
3D printing technology builds precise prototypes and concept models that best mimic how a product will look and feel. Only our PolyJet 3D printers can print multiple digital materials in a single build. That means closer simulation of products and a boost in creativity.

Drop-On-Demand & Smooth Curvature Printing
Most consumer inkjet printers use drop-on-demand technology. Our drop-on-demand 3D printing technology works by depositing up to 12000 droplets per second of a wax-like material onto a build plate in a layer-by-layer fashion to produce wax-like patterns ready for direct casting and other mold making methods of small precision part manufacturing. At 5000 drops-per-inch our proprietary Smooth Curvature Printing (SCP) technology is a jewelry industry favorite. These high precision printers give jewelry designers the freedom to produce creations of the finest feature detail with perfect symmetry and a precise surface finish.

MISSION & VISION

3D printing is bringing about the next industrial revolution. And we’re here to lead it. We’re here to help designers perfect their ideas. We’re here to help manufacturers remake the way they make things. We’re here to give individuals, teams and entire organizations 3D printing systems, services and solutions that transform the way they work.

We see the design process liberated, becoming more iterative and more creative. We see the manufacturing process transformed, becoming more agile and more efficient. We see more communication and collaboration bringing better products to market faster. We see Stratasys 3D Printers in every office, plant, lab and school on earth.

CULTURE

Stratasys is the unquestioned leader in 3D printing. We are makers of professional 3D printers and restless innovators, but great technology is only half of the story. We wouldn’t be the market leader without our talented employees.

We reward initiative and innovation, and encourage employee development.

Cooperation - We are dedicated to honest communication that creates clear expectations, fostering trust and teamwork.

Creativity - We value and reward innovative solutions through an open-minded environment that allows us to grow and enhance our business.

Commitment - We are committed to treating our internal and external customers with respect in a fair working environment while providing high quality, customer-driven solutions.

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