Senior Supplier Quality Engineer — Hybrid, Supplier Excellence

Regulatory Jobs; San Diego (CA); Hybrid; USD 100,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision

11 paid holidays

20 days PTO

401k with company match

Employee Stock Purchase Plan

Job summary

Tandem Diabetes Care is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor performance to ensure conformance with standards and risk reduction across global supply chains.

You will guide quality improvements, draft Quality Agreements, and collaborate with legal, process owners, and suppliers. Hybrid in San Diego with a strong quality engineering focus.

Qualifications

• Bachelor's degree in Engineering or equivalent required.
• Experience with supplier quality in regulated environments.
• Knowledge of ISO 13485, ISO 14971, ISO 9001.
• Strong audit and problem-solving skills.
• Experience with GMP and SPC.

Responsibilities

• Manage, lead and/or oversee supplier audits to meet company, quality, and regulatory requirements, including country-specific requirements for the suppliers; responsibilities extend to audits performed by 3rd party contractors.
• Generate, approve, review and monitor Supplier CAPA plans and activities to investigation and closure, including objective evidence of verification of effectiveness.
• Partner with Quality, process owners, legal and suppliers to create and revise Quality Agreements, as needed.
• Qualify, manage, and monitor supplier performance per Tandem supplier management approved processes. Identify gaps in current processes to develop, define, establish, and document new processes, as needed.
• Demonstrated ability to lead, develop, communicate & implement strategies for continuous improvement and development of existing or new suppliers and contract manufacturer.
• Ability to build relationships and work with suppliers or contract manufacturer to establish and maintain controlled consistent manufacturing processes and methods suitable to the nature of the components or assembly parts they supply.
• Independently leads and completes supplier activities such as supplier evaluations, change notifications, and validations.
• Facilitates quality oversite of Tandem’s 3rd party contract manufacturers.
• Ability to provide guidance to suppliers or contract manufacturer for quality engineering disciplines and statistics such as but not not limited to PFMECA, DMAIC, Lean, Problem-Solving tools, capability analysis, DOE, IQ/OQ/PQ validations.
• Responsible for reporting quality trends and information to management on the performance of suppliers or contract manufacturers.
• Follows up with suppliers for component related non-conformances identified during Tandem’s incoming inspection, in-process inspection, final test, quality complaints, and as applicable product returns.

Skills

Supplier quality

Quality engineering

QMS audits

GMP knowledge

Statistical methods

Problem solving

Independent work

GD&T knowledge

Education

Bachelor’s degree in Engineering

ISO Lead Auditor

Certified Quality Engineer

Tools

GD&T

Job description

Tandem Diabetes Care is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor performance to ensure conformance with standards and risk reduction across global supply chains.

You will guide quality improvements, draft Quality Agreements, and collaborate with legal, process owners, and suppliers. Hybrid in San Diego with a strong quality engineering focus.