Sr. Supplier Quality Engineer I (Contract Manufacturing)

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We innovate every day, put people first, and take a no-shortcuts approach that has propelled us to become a leader in the diabetes technology industry. Our company manufactures and sells the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology—an advanced predictive algorithm that automates insulin delivery. Many team members live with diabetes or have loved ones impacted by it, making this work deeply personal.

About the role

The Sr. Supplier Quality Engineer I is responsible for conducting and overseeing supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. This role provides quality guidance and support for supplier management activities such as qualifications, change notifications, audits, evaluations, and performance to ensure conformance to established standards, specifications, and risk reduction. The position acts as an instrumental team member to optimize and continuously improve supplier operations to meet department, business unit, and company objectives.

Responsibilities

• Manage, lead, and/or oversee supplier audits to meet company, quality, and regulatory requirements, including country-specific requirements for 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.
• Lead, develop, communicate, and implement strategies for continuous improvement and development of existing or new suppliers and contract manufacturers.
• Build relationships and work with suppliers or contract manufacturers to establish and maintain controlled, consistent manufacturing processes and methods suitable to the nature of the components or assembly parts they supply.
• Independently lead and complete supplier activities such as supplier evaluations, change notifications, and validations.
• Facilitate quality oversight of Tandem’s 3rd party contract manufacturers.
• Provide guidance to suppliers or contract manufacturers for quality engineering disciplines and statistics such as PFMECA, DMAIC, Lean, problem-solving tools, capability analysis, DOE, and IQ/OQ/PQ validations.
• Report quality trends and information to management on the performance of suppliers or contract manufacturers.
• Follow up with suppliers for component-related non-conformances identified during Tandem’s incoming inspection, in-process inspection, final test, quality complaints, and product returns.

Requirements

• 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 the ability to readily recognize non-conformances.
• Ability to explain audit results and influence others' understanding of audit observations in a culturally sensitive, tactful, and professional manner.
• Strong knowledge and application of principles outlined in Good Manufacturing Practices (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 diagrams, etc.
• Ability to work independently to identify potential quality issues and implement solutions.
• Understanding of mechanical drawings and specifications, including geometric dimensioning and tolerances (GD&T).
• Able to assert ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

Qualifications

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

Schedule

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 the office 2-3 days per week but may vary depending on business demands.

Pay

The starting base pay range for this position is $100,000 - $123,000 annually. Base pay will vary based on job-related knowledge, skills, experience, and may also fluctuate depending on candidate’s location and the overall job market.

Benefits

• Competitive compensation package including bonus.
• Health care benefits such as medical, dental, and vision available on your first day, as well as health savings accounts and flexible spending accounts.
• 11 paid holidays per year.
• A minimum of 20 days of paid time off (with accrual starting on day 1).
• Access to a 401k plan with company match.
• Employee Stock Purchase plan.