Sr. Supplier Quality Engineer

Katalyst CRO; San Francisco (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO in San Francisco seeks a Supplier Quality Engineer to qualify suppliers, support New Product Development, and drive quality improvements across the supply chain.

You will work with cross-functional teams to ensure GMP and industry standards are met, guiding CAPA activities and supplier audits for reliable healthcare products.

Qualifications

• Requires strong analytical, collaboration, communication, and influencing skills.
• Experience supporting NPD or design transfer to suppliers.
• Ability to lead cross-functional teams and drive quality decisions without direct authority.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers per company standards; administer Certified Supplier Program in receiving inspection.
• Monitor parts from acquisition through manufacturing; resolve supplier-related problems.
• Develop and prioritize supplier audit schedules to ensure GMP and quality standards.
• Provide Pre-Market Quality Engineering support to NPD in partnership with Component and Post-Market teams.
• Provide guidance and compliance for Supplier Quality throughout the NPD lifecycle.
• Collaborate with Component Engineers to develop Product Acceptance Sampling Strategy and Approved Supplier List.
• Define Receiving Inspection requirements and test method validation for internal Healthcare test methods.

Skills

Supplier Quality

NPD support

CAPA

Cross-functional leadership

Education

Baccalaureate degree

Master'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.