Supplier Quality Engineer - Med Devices & Aerospace

3D Systems Corporation; Littleton (CO); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation package

Paid leave (US)

401(k)

Health & wellness plans

Global team

Innovative culture

Talent development

Engagement opportunities

Job summary

3D Systems Corporation is seeking an Intermediate Supplier Quality Engineer to support global operations in Littleton, Colorado and Leuven, Belgium. You will ensure quality and compliance of supplier materials and components, partnering with suppliers and cross-functional teams worldwide.

The role focuses on supplier evaluation, qualification, performance monitoring, development, and regulatory compliance in a fast-paced, regulated manufacturing environment. Travel approx. 25% may be required.

Qualifications

• 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).

Responsibilities

• 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.
• Establish and maintain performance metrics and 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.
• 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.
• 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.
• 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.

Skills

Supplier quality engineering

Auditing

Problem solving

Communication

Education

Bachelor's degree in engineering/quality management

Tools

FMEA

Quality systems audits

Job description

3D Systems Corporation is seeking an Intermediate Supplier Quality Engineer to support global operations in Littleton, Colorado and Leuven, Belgium. You will ensure quality and compliance of supplier materials and components, partnering with suppliers and cross-functional teams worldwide.

The role focuses on supplier evaluation, qualification, performance monitoring, development, and regulatory compliance in a fast-paced, regulated manufacturing environment. Travel approx. 25% may be required.