Sr. Supplier Quality Engineer I

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.

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

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

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.

• •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.
• •Understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
• •Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

• •Bachelor’s degree in Engineering, preferably Electro-Mechanical Engineering or the equivalent education and applicable work experience.
• •ISO lead auditor, Certified Quality Engineer, or equivalent preferred.
• •Minimum 5 years’ related experience in Supplier Quality or related engineering positions
• •Familiarity in the production of PCB, PCBA, electro-mechanical assemblies and plastic molding is highly desirable.
• •Medical device manufacturing or FDA-regulated industry experience, highly preferred.
• •Supplier or lead quality auditing experience in a regulated company, highly preferred.
• •Experience in managing 3rd party contract manufacturers is