Quality Assurance Associate II (Monday - Thursday from 4:00 AM - 2:30 PM)
Quality Assurance Associate II (Monday - Thursday from 4:00 AM - 2:30 PM)
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1 Vacancy
Job Description
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. Wed 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 were so much more than that. Our companys 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 & WHERE YOULL WORK:
On-Site: This role is on-site four days a week Monday - Thursday from 4:00 AM - 2:30 PM at our San Diego facility due to the nature of the work involved.
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 DHRs work instructions SOPs 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.
- 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.
WHAT YOULL NEED:
1. Knowledge skills & abilities:
- 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).
2. Minimum certifications/educational level:
- Associates degree or combination of education and applicable job experience.
- Bachelors degree preferred.
3. Minimum experience:
- 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.
WHY YOULL LOVE WORKING HERE:
At Tandem we believe joy fuels excellence. Thats why weve 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 YOU WITH US!
We embrace the value that every single one of us brings to the table. But sometimes we forget that when we dont meet 100% of a job descriptions criteria maybe youre feeling that way right now We encourage you to apply anyway. Because we want you to be you with us.
Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age disability sex race religion or belief gender identity or expression marriage/civil partnership pregnancy/maternity or sexual orientation. We are an inclusive organization and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.
COMPENSATION:
The starting base pay range for this position is $21.00 - $24.00 per hour. Base pay will vary based on job-related knowledge skills experience and may also fluctuate depending on candidates 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.
YOU SHOULD KNOW:
Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check which includes a review of criminal history information.
Tandem has good cause to conduct a review of criminal history information of candidates for this position as this role may involve access to proprietary sensitive and/or confidential information including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers employees and stakeholders.
REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position please share!
SPONSORHSIP:
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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.
#LI-Onsite
Required Experience:
IC
Employment Type
Full-Time
