Quality Engineer

3D Systems • Littleton, CO

1d • $68,000 - $81,000 • Onsite

About The Position

The 3D Systems facility in Littleton, Colorado seeks an entry-level Quality Engineer to support excellence in the additive manufacturing of medical devices under the guidance of our Production Quality Manager. This vital role will learn and apply quality assurance principles across production and post-production processes for our state-of-the-art 3D printed medical solutions. The successful candidate will assist in implementing and maintaining rigorous quality systems that meet regulatory requirements while contributing to improvements in our manufacturing workflows. Join our innovative team where you will develop your skills and directly impact patient outcomes by helping ensure 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.

Requirements

• Bachelor's degree in Engineering or related technical field required.
• Relevant experience in regulated cGMP environments such as medical device manufacturing or pharmaceuticals required.
• Foundational understanding of quality assurance and reliability principles in product development and/or manufacturing operations.
• Basic knowledge of cGMP requirements, ISO 13485 Quality Management Systems, and/or AS9100 standards.
• Technical aptitude with ability to learn and interpret specifications across diverse products and materials.
• Analytical thinking skills with eagerness to support and improve engineering processes for advanced technology implementations.
• Ability to create clear technical documentation and reports with attention to detail.

Responsibilities

• 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, materials, 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.
• Analytics and Data Gathering : Strong aptitude for data analytics and data gathering preferred.

Benefits

• Competitive Compensation Package: $68,000 - $81,000 per year.
• 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.
• 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.
• Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team operates across more than 13 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 This Job Offers

• Job Type: Full-time
• Career Level: Entry Level