Tandem Diabetes Care, Inc.
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at Tandem Diabetes Care, Inc.
What you’ll be doing:
As a Quality Engineer you’ll be responsible for providing quality guidance and support for product launch, sustaining engineering, production and quality system activities to assure conformance to established specifications. We’re seeking a candidate who has a strong understanding of quality processes and uses this knowledge to facilitate the optimization and continuous improvement of internal operations to meet department, business unit and company objectives.
Other responsibilities include:
- Serves as a Quality representative on product launch and sustaining engineering project teams.
- 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 quality related problems with products and processes; provides input on problem resolutions.
- 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 (QMS updates, Procedural changes, etc.)
- Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable.
- Independently completes activities such as Risk Analysis, Process Capability Analysis (Cpk), and Gage R&R; assists with V&Vs.
- 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 assist 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.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. “In Tandem” means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.
We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild
What you need for this position:
- Bachelor’s degree in Engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience.
- 2 years’ experience working as a Quality Engineer in a medical device, manufacturing or an FDA-regulated industry.
- Demonstrates intermediate knowledge of Quality Engineering principles and best practices.
- Proficient knowledge of quality standards (ISO 13485, 21CFR Part 820, and other related standard associated to assigned role).
- Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
- Understands the use of test and measurement equipment, e.g. optical comparator, and other inspection equipment, data acquisition, pressure, temperature meters, and mechanical measurement tools.
- Proficient in statistical techniques including sampling theory, probability, capability analysis, and SPC.
- Capable of using problem solving methodologies: why-why analysis, cause and effect diagram, etc.
- Experience in a GMP or ISO environment preferred.
What’s in it for you?
We’ve got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!
Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.