Senior Supplier Quality Engineer - Audits & CAPA

Tandem Diabetes Care Europe B.V.; United States; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Tandem Diabetes Care is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor supplier performance to ensure quality materials for our medical devices.

You will guide quality improvement initiatives and collaborate across Quality, Legal, and supplier teams. You will oversee audits (including 3rd party contractors), CAPA plans, and quality agreements, driving continuous improvement and compliant manufacturing processes with contract manufacturers

Qualifications

• Direct experience with suppliers and contract manufacturers who produce components or assemblies in a regulatory environment.
• Proficient knowledge of Quality Engineering policies and standards including ISO 13485, ISO 14971, ISO 9001.
• Competent in QMS Audit and Process Audit practices with ability to recognize non-conformances.
• Ability to explain audit results clearly and influence others in a professional, culturally sensitive manner.
• Strong knowledge of GMP.
• Solid background in statistics: sampling, probability, capability, SPC.
• Experience with problem-solving methodologies (5-Why, fault tree, cause-and-effect).
• Ability to work independently to identify quality issues and implement solutions.

Responsibilities

• Lead, manage, and oversee supplier audits to meet company, quality, and regulatory requirements, including 3rd party audits.
• Develop and monitor Supplier CAPA plans and verify effectiveness with objective evidence.
• Collaborate with Quality, process owners, legal, and suppliers to create or revise Quality Agreements.
• Qualify and monitor supplier performance per approved processes and close gaps with new procedures.
• Drive continuous improvement and development of suppliers and contract manufacturers.
• Foster relationships with suppliers/contract manufacturers to ensure controlled, consistent manufacturing processes.
• Lead supplier evaluations, change notices, and validations.
• Provide guidance on quality engineering disciplines and statistics to suppliers.
• Report quality trends and supplier performance to management.
• Follow up on component-related non-conformances identified during inspection or returns.

Skills

Supplier audits

ISO 13485/14971/9001

QMS auditing

Audit results communication

GMP knowledge

Statistics (SPC)

Root cause analysis

Independent work

Contract manufacturers

Job description

Tandem Diabetes Care is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor supplier performance to ensure quality materials for our medical devices.

You will guide quality improvement initiatives and collaborate across Quality, Legal, and supplier teams. You will oversee audits (including 3rd party contractors), CAPA plans, and quality agreements, driving continuous improvement and compliant manufacturing processes with contract manufacturers