Sr. Supplier Quality Engineer I

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

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take the "no-shortcuts" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

The Sr. Supplier Quality Engineer I is responsible for conducting and overseeing supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. An experienced team member providing quality guidance and support for supplier management activities such as qualifications, change notifications, audits, evaluations and performance to assure conformance to established standards, specifications and risk reduction. Acts as an instrumental member of the team to optimize and continuously improve supplier operations to meet department, business unit and company objectives. Provides suggestions, guidance and feedback to suppliers to ensure quality materials and components are delivered for use in Tandem's product operations.

• 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 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.

WHEN & WHERE YOU'LL WORK:

Hybrid: This role will be a mix of in-office work at our Barnes Canyon facility in San Diego, CA and remote work. This position is expected to be in office 2 days per week but may vary depending on business demands.

WHAT YOU'LL NEED:

• Direct experience with suppliers and contract manufacturers who produce components or assembly parts in a regulatory environment.
• Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, ISO 14971, ISO 9001 and other appropriate industry standards.
• Competent in QMS Audit and Process Audit practices with ability to readily recognize non-conformances.
• Must be able to explain audit results and influence other's understandings of audit observations in a culturally sensitive, tactful, and professional manner.
• Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
• Strong knowledge of and demonstrated experience using statistical techniques: sampling theory, probability, capability, and SPC.
• Strong knowledge of and demonstrated experience using problem solving methodologies: 5-why analysis, fault tree analysis, cause and effect diagram etc.
• Ability to work independently to identify potential quality issues and implement solutions.
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