Supplier Qual Engineer II - Exempt

Join our team in Boulder, CO, where you will play a key role in ensuring 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 our supply chain.

Responsibilities

• Drive and manage supplier quality activities related to projects including 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 regularly to ensure 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 test methods.
• Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams.
• 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.

Must Have: Minimum Requirements

• 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