Sr. Supplier Quality Engineer I (Contract Manufacturing)

Tandem Diabetes; San Diego (CA); Hybrid; USD 100,000 - 123,000; Full time

Benefits offered by this job

Health care benefits

11 paid holidays per year

20 days paid time off

401k with company match

Employee Stock Purchase plan

Job summary

Tandem Diabetes Care, a leader in diabetes technology, seeks a Sr. Supplier Quality Engineer I in San Diego. The role focuses on supplier audits, qualifications, and performance to ensure conformance to standards and risk reduction. You will guide supplier management activities to deliver quality components for Tandem products.

Hybrid work in San Diego with 2-3 days in the office; strong background in QA, supplier audits, and GMP is preferred. Competitive compensation and benefits are offered.

Qualifications

• Direct experience with suppliers and contract manufacturers in a regulated environment.
• Proficient knowledge of ISO 13485, ISO 14971, ISO 9001 and related standards.
• Strong knowledge of GMP and statistical methods.
• Ability to lead audits and drive corrective actions.

Responsibilities

• Manage, lead and oversee supplier audits to meet quality and regulatory requirements.
• Generate, approve, review and monitor Supplier CAPA plans and activities.
• Partner with quality, process owners, legal and suppliers to create and revise Quality Agreements.
• Qualify, manage, and monitor supplier performance per approved processes.
• Lead supplier evaluations and oversight of contract manufacturers.

Skills

Quality engineering

Supplier management

Auditing

Statistical methods

GMP/GDQ

Education

Bachelor's degree in Engineering

Regulatory knowledge

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 Tandems product operations.

The Sr. Supplier Quality Engineer I are also responsible for:

• 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 Tandems 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 Tandems 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 2-3 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.
• 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.

EXTRA AWESOME:

• 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 a plus.

COMPENSATION & BENEFITS:

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. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

• health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving 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.
• an Employee Stock Purchase plan.

Learn more about Tandems benefits here!

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHY YOU'LL LOVE WORKING HERE:

At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

REFERRALS:

We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

#LI-KT1 #LI-Hybrid

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company's pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature