Sr Quality Engineer I

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 type 1 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:

On-Site: This role is on-site five days a week at our Barnes Canyon office due to the nature of the work involved.

A DAY IN THE LIFE:

An experienced team member in a hardware development environment providing quality guidance and support for product development and launch, sustaining engineering, and quality system activities to assure conformance to established specifications and risk reduction. Works independently to optimize and continuously improve internal operations to meet department, business unit and company objectives.  Also provides expertise and guidance to ensure quality systems are in place across the hardware development organization that improves quality of our devices as well as our business operations.

Sr. Quality Engineer I’s at Tandem are also responsible for:

• Serves as a Quality lead on hardware product development and sustaining engineering project teams.
• Reviews and approves product and process changes/new designs to assure they are developed, verified, validated and documented in accordance with regulatory requirements.
• Assures all actions required to optimize the quality, manage the risk, and maintain the compliance of all products, planned and completed, and that the results drive quality and quality system actions.
• Analyzes and solves quality related problems with products and processes.
• Provides input and contributes content to IQ/OQ/PQ development for processes and equipment.
• Design and perform test method validation
• Manufacturing and/or test fixture qualification (requirements, protocols, execution, test report)
• Support part Non-Conformity Reports (NCRs)
• Perform sterilization validation, package testing, and biocompatibility testing
• Reviews and approves CO’s as well as provides quality input to support closure
• Provides quality input to Complaint, FA, CAPA investigations Independently completes such activities in Risk Analysis, Process Capability Analysis (Cpk), DFM, Design Reviews, Gage R&R, DOEs, V&V Testing, and reliability testing activities.
• Facilitates or participates in cross-functional or cross-divisional process improvement teams to drive product development quality excellence and cost savings initiatives.
• Reviews and analyzes project and customer requirements and assists project teams in tailoring and using company procedures, methods, templates and tools.
• Collects process metrics and lessons learned, reviews and evaluates processes and work products and recommends improvements as appropriate.
• Supports and leads, internal and external audits as scheduled to build the quality system and reduce risk.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Other responsibilities as assigned.

WHAT YOU’LL NEED:

Knowledge, skills & abilities:

• 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).
• Understands the use of all test and quality measurement equipment.
• Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.
• Previous experience generating and analyzing quality metrics.
• Demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysi