“In Tandem” means together, and we strive to embody that in every aspect of our business. Whether your office-based or fully remote, Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and the healthcare providers supporting them through a positively different experience.
At Tandem, we strive to put our values into action. Our “Team Up”, “No shortcuts” approach has propelled us to be an industry leader and make significant strides in the diabetes technology space. We are proud to be the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Watch our latest video to see our product features and capabilities here: t:slim X2™ Insulin Pump with Control-IQ™ Technology
A DAY IN THE LIFE:
An experienced team member providing quality guidance and support for product launch, sustaining engineering, production 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 systems are in place across the organization that improves quality of our devices as well as our business operations.
PRIMARY DUTIES & RESPONSIBILITIES:
Serves as a Quality lead on 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.
Reviews and approves ECO’s as well as provides quality input to support closure (IMS updates, Procedural changes, etc.)
Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable.
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 operational 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.
YOU’RE AWESOME AT:
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).
Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
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 analysis, cause and effect diagram etc.
Ability to work independently to identify potential quality issues and propose solutions.
Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
Able to recognize non-conformances from accepted and documented practices.
Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
Skilled at promoting team cooperation and a commitment to team success.
Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.
Minimum certifications/educational level:
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 in a GMP or ISO environment preferred.
WHAT’S IN IT FOR YOU?
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.
We love a good referral! If you know someone that would be a great fit for this position, please share!