Senior Supplier Quality Engineer — Medical Devices (Hybrid)

Tandem Diabetes Care Inc.; California; Hybrid; USD 100,000 - 123,000; Full time

Benefits offered by this job

Health benefits

Paid time off

401k + match

Employee Stock Purchase Plan

Job summary

Tandem Diabetes Care Inc. is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor current supplier performance.

You will provide quality guidance and drive continuous improvement in supplier operations to align with company objectives. You will partner with Quality, process owners, and suppliers to create and revise Quality Agreements, qualify suppliers, and manage contract manufacturers.

Qualifications

• Direct experience with suppliers and contract manufacturers in a regulated environment.
• Proficient knowledge of Quality Engineering policies, principles and best practices (ISO 13485, ISO 14971, ISO 9001).
• Competent in QMS Audit and Process Audit practices with ability to recognize non-conformances.
• Strong GMP knowledge and application.
• Solid statistical techniques including sampling, capability, SPC.
• Experience with problem-solving methodologies (5-why, fault tree, cause-effect).
• Ability to work independently to identify quality issues and implement solutions.
• Understanding of GD&T and mechanical drawings/tolerances.
• Ability to present information clearly to influence others.

Responsibilities

• Lead, oversee and/or participate in supplier audits to meet regulatory requirements including third-party audits.
• Qualify, manage and monitor supplier performance per approved processes.
• Develop and implement CAPA plans and verify effectiveness with objective evidence.
• Collaborate with Quality, process owners, and suppliers to revise Quality Agreements.
• Identify process gaps and help define new, documented procedures.
• Guide continuous improvement and supplier development strategies.
• Oversee and mentor contract manufacturers and ensure controlled manufacturing processes.

Skills

Quality Engineering

QMS Audits

Process Audits

Statistical Methods

Problem Solving

GD&T

GMP Knowledge

Supplier Management

Education

Bachelor’s degree in Engineering

ISO Lead Auditor

Certified Quality Engineer

Job description

Tandem Diabetes Care Inc. is seeking a Sr. Supplier Quality Engineer I to lead supplier audits, qualify new suppliers, and monitor current supplier performance.

You will provide quality guidance and drive continuous improvement in supplier operations to align with company objectives. You will partner with Quality, process owners, and suppliers to create and revise Quality Agreements, qualify suppliers, and manage contract manufacturers.