Senior Supplier Quality Engineer: NPD & GMP Leader

Katalyst CRO; Louisville (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Colorado is seeking an experienced Quality Engineer specializing in Supplier Quality to ensure parts, materials, and services meet GMP and company standards. You will qualify suppliers, monitor performance, and support audits within a healthcare-focused environment.

Collaborate with Component Engineers and NPD teams to develop sampling strategies, maintain approved supplier lists, and drive continuous improvement.

Qualifications

• Requires a Bachelor's degree and minimum 4 years of relevant experience or a Master's with 2 years.
• Experience supporting NPD or design transfer to suppliers.
• Strong analytical, collaboration, communication and influencing skills.
• Ability to lead cross-functional teams and drive quality decisions without direct authority.

Responsibilities

• Ensure suppliers deliver quality parts, materials and services; qualify suppliers to company standards.
• Monitor parts from acquisition through manufacturing and resolve supplier-related problems.
• Develop and prioritize supplier auditing schedule to ensure GMP and quality standards.
• Evaluate suppliers' internal functions and provide feedback on performance.
• Provide Pre-Market Quality Engineering support to NPD with Engineering teams to deliver quality parts and prevent defects.
• Provide guidance for supplier quality engagement across the NPD lifecycle and ensure compliance with standards.
• Collaborate with Component Engineers to develop sampling and Q deployment for new products.
• Define receiving inspection requirements and test method validation for internal Healthcare methods.

Skills

Quality mindset

Cross-functional collaboration

Analytical thinking

CAPA and problem solving

NPD support

Education

Bachelor's degree

Job description

Katalyst CRO in Colorado is seeking an experienced Quality Engineer specializing in Supplier Quality to ensure parts, materials, and services meet GMP and company standards. You will qualify suppliers, monitor performance, and support audits within a healthcare-focused environment.

Collaborate with Component Engineers and NPD teams to develop sampling strategies, maintain approved supplier lists, and drive continuous improvement.