Sr Supplier Quality Engineer

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

• Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes 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.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• 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 Healthcare to provide customers with the highest quality and reliable products.
• Provides 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 to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates 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 Healthcare Test Methods.

Roles And Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes 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.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• 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 Healthcare to provide customers with the highest quality and reliable products.
• Provides 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 to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates 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 Healthcare Test Methods.

Education and Experience

• Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience
• Experience supporting new product development (NPD) or design transfer to suppliers.
• Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross‑functional teams and drive quality decisions without direct authority.
• Partner with cross‑functional teams to support supplier changes, nonconformances, and CAPA activities.