Senior Supplier Quality Engineer - Hybrid Role

Tandem Diabetes Care, Inc.

San Diego (CA)

Hybrid

USD 100,000 - 123,000

Full time

8 days ago

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Benefits offered by this job

Health care benefits
401k with company match
Employee Stock Purchase Plan
Paid holidays

Job summary

Tandem Diabetes Care, Inc. is seeking a Sr. Supplier Quality Engineer I to oversee supplier audits, qualify new suppliers, and monitor performance to ensure conformance to standards and risk reduction.

The role provides quality guidance for supplier management, qualification, changes, audits, and performance optimization. Hybrid work arrangement at our San Diego facility with potential remote work; in-office 2 days per week, with business-driven variability.

Qualifications

  • Direct experience with suppliers and contract manufacturers in a regulated environment.
  • Proficient knowledge of Quality Engineering policies and standards (ISO 13485, ISO 14971, ISO 9001).
  • Experience with QMS Audit and Process Audit practices and identifying non-conformances.
  • Ability to explain audit results clearly and influence others in a professional manner.
  • Strong GMP knowledge and statistical methods application.
  • Knowledge of GD&T and mechanical drawings.
  • Ability to work independently to identify quality issues and implement solutions.

Responsibilities

  • Lead supplier audits to meet company, quality, and regulatory requirements (including 3rd party audits).
  • Create and monitor Supplier CAPA plans with effectiveness verification.
  • Develop and update Quality Agreements with internal teams and suppliers.
  • Qualify and monitor supplier performance per approved processes; close gaps.
  • Lead continuous improvement strategies for suppliers and contract manufacturers.
  • Collaborate with suppliers to ensure controlled manufacturing processes.

Skills

Supplier quality
QMS audits
GMP knowledge
GD&T
Statistical methods
Contract manufacturers
Audit leadership

Education

Bachelor’s degree in Engineering
ISO lead auditor (preferred)
Certified Quality Engineer (preferred)

Tools

PCB/PCBA familiarity

Job description

Tandem Diabetes Care, Inc. is seeking a Sr. Supplier Quality Engineer I to oversee supplier audits, qualify new suppliers, and monitor performance to ensure conformance to standards and risk reduction.

The role provides quality guidance for supplier management, qualification, changes, audits, and performance optimization. Hybrid work arrangement at our San Diego facility with potential remote work; in-office 2 days per week, with business-driven variability.

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