Quality Assurance Associate II (Friday - Sunday, 5:00am - 5:30pm)

Full-time 8 months ago
Employment Information

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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since 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 tandemdiabetes.com.

A DAY IN THE LIFE:

  • Performs In-process, Final Inspection and Final Approval of Product :
    • Reviews and approves manufacturing Design History Records (DHRs), associated test reports and records and reports abnormalities.
    • Verifies training and other records for compliance to specifications.
    • Assists with resolving non-conformances occurring with in-process and finished products.
    • Provides quality oversight of manufacturing process/final packaging.
    • Updates departmental spreadsheets and statistics.
    • Assists in revising DHR’s, work instructions, SOP’s, process risk documents, etc.
    • Maintains department documentation and inventory of retained materials.
    • Reviews and approves manufacturing records such as test reports and 5S log-sheets.
    • Assists with calibration/preventive maintenance (PM) program:
    • Checks PM logbooks on manufacturing equipment for completeness and accuracy.
    • Verifies area equipment is within calibration specifications.
  • May assist with Incoming Inspections as required.
  • Assists with Internal audits and participates in 3rd party audits.
  • 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.
  • Performs other assignments or projects as directed.

YOU’RE AWESOME AT:

  • Deep understanding of GMP regulations and Process Controls, including document review, in-process and final acceptance criteria, identification and traceability requirements, and segregation of materials.
  • Able to effectively share information and ideas within and outside of department in written or verbal form; able to put forth own ideas and gain understanding from others.
  • Proficient at supporting effective interactions between team members and among cross-functional teams.
  • Demonstrated ability to schedule and coordinate project priorities and resources and to produce high quality work.
  • Proficient experience with MS Office suite (Word, Excel, Outlook).
  • Associate’s degree or combination of education and applicable job experience.
  • Bachelor’s degree preferred.
  • 5 plus years’ relevant quality and/or manufacturing experience in a FDA regulated industry, preferably medical devices
  • Experience with QSRs, QC testing methods and general knowledge of GMP requirements for production.
  • Experience with lot release, document review, and in-process inspection.

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.

COMPENSATION:

The starting base pay range for this position is $17.78 - $24.00 per hour. 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.

**This is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance.

Tandem offers an environment where you are encouraged to be imaginative and intuitive, with the ability to envision what’s possible for people living with diabetes. We aim to uplift, encourage, and support everyone in the diabetes community. Tandem put’s people first and firmly believe that we can make a positively different impact by bringing the right people to improve ideas, solutions, and our company!

YOU SHOULD KNOW:

Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.

REFERRALS:

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

If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.

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.

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