Supplier Quality Engineer II

Supplier Quality Engineer II (Contract through November 2026 // Boulder, CO):

Play a key role in client’s quality and compliance by maintaining and updating the Approved Supplier List, supporting supplier-related compliance projects, and ensuring our suppliers meet rigorous quality standards. You’ll qualify new suppliers, lead audits to uphold GMP and regulatory requirements, and work closely with engineering teams to resolve issues and implement effective quality strategies for new products. This position offers the opportunity to directly influence product reliability, patient safety, and continuous improvement across client’s supply chain.

Top 3 skills:

1. Experience with supplier audits, qualification processes, and maintaining Approved Supplier Lists to ensure compliance with GMP and regulatory standards.
2. Strong understanding of quality management systems, regulatory requirements, and compliance project support within a manufacturing or medical device environment.
3. Proficiency in identifying, investigating, and resolving supplier-related issues using structured problem-solving methodologies.

Education Required: Requires a Bachelor’s Degree, preferably in engineering, technology, or science

Years’ Experience Required: 2 years minimum

Duties:

• Drive and manage supplier quality activities related to projects (approved supplier list updates, PPAPs, and general project support).
• Ensure that suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.
• Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal client Test Methods.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow client to provide customers with the highest quality and reliable products.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Ensure that suppliers deliver quality parts, materials, and services.

Must Have:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
• Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience

Nice to Have:

• Strong written and verbal communication skills
• Solid presentation and computer skills (Excel/Word/PowerPoint/Projects, etc.)
• Project management skills
• Self-starter, self-motivated attitude with the ability to multitask and thrive in a fast-paced environment
• Excellent interpersonal communication skills