Sr. Quality Engineer – Risk Assessment

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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 3 days per week but may vary depending on business demands. 

A DAY IN THE LIFE:

Quality Engineering is responsible for product and service quality evaluation and control. Sr QE cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

Sr. Quality Engineers – Risk Assessment at Tandem are also responsible for:

• Leads Post Market Risk Management (ISO 14971) activities, may lead cross functional teams in planning, analyses (pFMECA, Fault Tree Analysis, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device.
• Provides support in conducting root cause investigation, preparation of CAPA, data analysis and any regulatory responses where risk evaluation is required.
• Monitor and lead activities related to post market risk management e.g., p-chart analysis meeting and investigation, update of risk assessments etc.
• Escalate risk management issues to management.
• Monitor the performance of risk estimation criteria to ensure it is providing the appropriate result.

WHAT YOU’LL NEED:

• Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.
• 5 years’ experience working as a Quality Engineer in a medical device, manufacturing, or an FDA-regulated industry.
• Experience writing post market risk assessment preferred
• Experience in a GMP or ISO environment preferred.
• Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices.
• Proficient knowledge of quality standards (ISO 13485, 21CFR Part 820, ISO 14971 and other related standard associated to assigned role).
• Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
• Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.
• Draws on best practices and comprehensive technical knowledge to advise internal/external customers in own area of expertise.
• Uses deep subject matter expertise, influence and process skills to help the enterprise clients and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
• Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.
• Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
• Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

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