Job Information
3D Systems Quality Engineer - 25000059 in Littleton, Colorado
What We Are Looking For
The 3D Systems facility in Littleton, Colorado seeks an exceptional Intermediate Quality Engineer to ensure excellence in the additive manufacturing of medical devices under the guidance of our Production Quality Manager. This vital role will champion quality assurance across production and post-production processes for our state-of-the-art 3D printed medical solutions. The successful candidate will implement and maintain rigorous quality systems that meet regulatory requirements while continuously driving improvements to our manufacturing workflows. Join our innovative team where your expertise will directly impact patient outcomes by ensuring our life-changing medical devices consistently exceed quality expectations!
Onsite
This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.
What's in it for You!
Competitive Pay: $80,000 - $98,000 per year. Our employees are the best part of our company. We want you to feel valued, appreciated, and included. Because of this, we make sure your hard work is recognized. Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays and a flexible working schedule through our paid time off (PTO) policy.Yep, you read that correctly. We are a Company that values you and makes sure you take time for yourself. 401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution. Comprehensive Health & Wellness Plans: We offer a comprehensive benefit package that includes medical, dental and vision coverage, company-paid short-term and long-term disability insurance, as well as company-paid basic life insurance that supports you during your career with us. We believe that taking care of our employees is essential, and these benefits reflect our commitment to your health, security, and peace of mind. Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 15 countries worldwide. Experience a workplace comprised of talented individuals who are passionate about serving our customers and each other. Innovative Culture: Innovation is at the heart of what we do! Since our founding in 1986 by Chuck Hull, the inventor of 3D printing, we have continuously pushed the boundaries of what is possible with additive manufacturing. When you join 3D, you will have the opportunity to work with cutting edge technology in an innovative and collaborative culture! Talent Development: At 3D Systems, we invest in talent programs to support employees with opportunities to grow, contribute, develop, and thrive in their careers. Connection & Engagement Opportunities: We strive to cultivate an environment where our diverse global workforce can connect and thrive. Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program, are just a few examples of how you will be empowered to build connections, celebrate wins, and make a meaningful impact.
What You Will Do
Quality Management System Support: Support execution, maintenance, and improvement of Quality Management Systems in accordance with USFDA CFR 820, ISO 13485, and AS9100 requirements. Technical Issue Resolution: Participate in complaint, CAPA, and NCR investigations, gathering product conformity information and coordinating with stakeholders to optimize quality while remediating processes, updating work instructions, and minimizing scrap. Product Quality Process Development: Utilize existing processes and inspection methods while developing new capabilities to meet technical requirements, including specifying, financially justifying, developing, and implementing new quality assurance methods. Process and Product Validation: Participate in cross-functional teams to develop and execute test protocols for verification and validation of updated products, material , equipment, software, and processes, performing statistical analysis to assess design and manufacturing viability. Measurement System Analysis: Identify and evaluate measurement systems to ensure accuracy, precision, and stability in product conformity assessments.
Qualifications
What You Will Bring
Education
Bachelor's degree in Engineering or related technical field required.
Experience
2-4 years of relevant experience in regulated cGMP environments such as medical device manufacturing or pharmaceuticals required.
Knowledge, Skills & Abilities
Quality assurance and reliability expertise supporting product development and/or manufacturing operations. Working knowledge of cGMP requirements, ISO 13485 Quality Management Systems, and/or AS9100 standards. Strong technical literacy with ability to interpret specifications across diverse products and materials. Analytical mindset with capability to develop and enhance engineering processes for advanced technology implementations. Proficiency in creating comprehensive technical documentation and reports.
Applications accepted online through May 13, 2025