Supplier Quality Engineer II

3D Systems

Littleton, CO

Who We Are

3D Systems Healthcare is a dynamic and leading enterprise, specialized in 3D Printing of metal and other material components. 3D Systems in Littleton, CO is not only a technology developer but also a technology user. This makes us a strong innovation partner for clients in the aerospace, industrial, medical and dental sectors. We are experts in digital workflows, patient-specific devices, and five different kinds of 3D printing. The Quality department serves both the Virtual Surgical Planning as well as the Contract Manufacturing product lines with plastic and metal additive manufacturing.

What We Are Looking For:

Supplier Quality Engineer II

3D Systems is seeking a highly skilled and experienced Supplier Quality Engineer II to join our dynamic team in the medical device and aerospace industry, supporting both of our locations in Littleton, CO and Leuven, Belgium. As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and reliability of the components and materials supplied by external vendors. Your primary responsibility will be to assess, develop, and manage the quality systems and processes of our suppliers, while collaborating closely with cross-functional teams to drive continuous improvement and maintain regulatory compliance.

What You Will Do:

Supplier Evaluation and Qualification:

·         Conduct comprehensive assessments of potential suppliers to evaluate their capability to meet quality standards and regulatory requirements.

·         Collaborate with the procurement team to establish and maintain an approved supplier list based on rigorous qualification criteria.

·         Drive supplier corrective actions and improvement plans as necessary to address non-conformities and ensure adherence to quality standards.

Supplier Performance Monitoring:

·         Establish and maintain performance metrics and key performance indicators (KPIs) to monitor supplier performance and identify areas for improvement.

·         Conduct regular supplier audits to evaluate compliance with quality management systems, applicable standards, and contractual obligations.

·         Analyze supplier quality data and trends to proactively identify and address potential risks or quality issues.

Supplier Development and Collaboration:

·         Provide technical guidance and support to suppliers to enhance their quality systems, processes, and manufacturing capabilities.

·         Foster strong relationships with suppliers through effective communication, collaboration, and joint problem-solving to ensure mutual success.

Regulatory Compliance and Documentation:

·         Ensure suppliers meet all relevant regulatory and industry standards, such as ISO 13485, FDA QSR, AS9100, or other applicable requirements.

·         Collaborate with cross-functional teams to review and approve supplier-related documentation, including quality agreements, supplier audits, and corrective action plans.

·         Stay updated on industry regulations and changes, providing guidance and support to ensure compliance across the supply chain.

Risk Management:

·         Identify potential risks within the supply chain and develop risk mitigation strategies.

·         Conduct risk assessments for critical suppliers, materials, and components to ensure continuity of supply and product quality.

·         Participate in cross-functional teams to resolve quality issues and implement preventive measures.

What You Will Bring

·         Bachelor's degree in engineering, quality management, or a related field.

·         Minimum of 3 years of experience in supplier quality engineering, preferably in the medical device or aerospace industry.

·         In-depth knowledge of quality management systems, regulations, and standards applicable to medical devices (e.g., ISO 13485, FDA QSR) or aerospace (e.g., AS9100).

·         Experience conducting supplier audits and managing supplier corrective actions.

·         Familiarity with risk management principles and tools (e.g., FMEA).

·         Excellent analytical and problem-solving skills.

·         Effective communication and interpersonal skills to collaborate with internal and external stakeholders.

·         Ability to work in a fast-paced environment and manage multiple priorities effectively.

·         Willingness to travel to supplier sites as required (approximately 25% travel).

The Good Stuff!

    • Salary Range: $76,400 - $91,700 annually (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data.
    • In addition to a salary, this position is eligible for an annual bonus based upon company performance.
    • 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 8 holidays per year are also provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.