Quality Assurance Associate II (Temp to Hire)

A Quality Assurance Associate at 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.

WHEN & WHERE YOU’LL WORK:

On-Site: This role is on-site four days a week at our San Diego office due to the nature of the work involved.

Schedule: This position has a schedule of 2:30 pm - 1:00 am (PT). 

Please note that this 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 on business need and job performance.

WHAT YOU’LL NEED:

• 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.

• 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).

COMPENSATION & BENEFITS:

The starting base pay range for this position is $22.50 - $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. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.  You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.  Learn more about Tandem’s benefits here!

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.

SPONSORSHIP: 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.