Sr. Supplier Quality Engineer
Katalyst CRO · San Francisco, CA · Yesterday
On-siteQuality AssuranceContract
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, meeting good manufacturing practices (GMP) and quality standards.
- Evaluates suppliers' internal functions to assess overall performance and provides feedback on their operations.
- Provides Pre‑Market Quality Engineering support to New Product Development (NPD) in partnership with Component Engineering and Post‑Market Supplier Quality Teams to deliver quality parts, prevent defects, and enable the delivery of reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts, implementing strategies for product quality, continuous improvement, and compliance with industry, regulatory, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, coordinate the Approved Supplier List, deploy Supplier Owned Quality, and create Control Plans for new products.
- Defines Receiving Inspection requirements and validates associated test methods for all internal Healthcare test methods.
Education and Experience
- Baccalaureate degree with a minimum of 4 years of relevant experience, or a Master’s degree with a minimum of 2 years of 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.
- Partnered with cross‑functional teams to support supplier changes, nonconformances, and CAPA activities.