Hybrid Senior Supplier Quality Engineer I — Impactful QA

Tandem Diabetes; San Diego (CA); Hybride; USD 100 000 - 123 000; Plein temps

Avantages offerts par ce poste

Health benefits from day 1

11 paid holidays

20 days PTO

401k with company match

Employee Stock Purchase Plan

Résumé du poste

The Sr. Supplier Quality Engineer I at Tandem Diabetes Care leads supplier audits, qualification of new suppliers, and ongoing performance monitoring to ensure conformance to ISO and GMP standards.

You will collaborate with Quality, process owners, and suppliers to implement CAPA plans, quality agreements, and continuous improvements across our manufacturing partners in a regulated environment.

Qualifications

• Direct experience with suppliers and contract manufacturers in regulated environments.
• Proficient knowledge of ISO 13485, 14971, 9001 and related standards.
• Strong knowledge of GMP and SPC; experience with problem solving methodologies (5-why, fault tree, cause and effect).
• Ability to lead supplier audits and manage CAPA plans.
• Understanding of mechanical drawings and GD&T.

Responsabilités

• Lead supplier audits to meet quality and regulatory requirements.
• Qualify, manage, and monitor supplier performance.
• Develop and monitor Supplier CAPA plans and verify effectiveness.
• Collaborate with Quality, process owners, legal and suppliers to create quality agreements.
• Drive continuous improvement in supplier operations and contract manufacturers.

Connaissances

Auditing

Quality engineering

Statistical methods

Problem solving

Formation

Bachelor’s degree in Engineering

Outils

GD&T

SPC

DOE

IQ/OQ/PQ

Description du poste

The Sr. Supplier Quality Engineer I at Tandem Diabetes Care leads supplier audits, qualification of new suppliers, and ongoing performance monitoring to ensure conformance to ISO and GMP standards.

You will collaborate with Quality, process owners, and suppliers to implement CAPA plans, quality agreements, and continuous improvements across our manufacturing partners in a regulated environment.