Quality Assurance Associate II

Position Summary

Perform inspection and release of manufacturing goods during the manufacturing process through routine and non‑routine verification and review of in‑process and finished products under general supervision and according to Quality Test Procedures (QTP) and Standard Operating Procedures (SOPs).

• Compile data for documentation of test procedures and assist with report preparation.
• Work a shift schedule of Friday, Saturday, and Sunday from 5:00 a.m. to 5:30 p.m. (on‑site).
• Perform in‑process, final inspection, and final approval of product: review and approve Design History Records (DHRs), associated test reports and records, and report abnormalities.
• Verify training and other records for compliance with specifications.
• Assist with resolving non‑conformances occurring with in‑process and finished products.
• Provide quality oversight of manufacturing process and final packaging.
• Update departmental spreadsheets and statistics.
• Assist in revising DHRs, work instructions, SOPs, process risk documents, etc.
• Maintain department documentation and inventory of retained materials.
• Review and approve manufacturing records such as test reports and 5S log‑sheets.
• Assist with calibration/preventive maintenance program: check PM logbooks on manufacturing equipment for completeness and accuracy, and verify that area equipment is within calibration specifications.
• Assist with incoming inspections as required.
• Assist with internal audits and participate in third‑party audits.
• Confirm completion of required training plan before assuming job responsibilities.
• Ensure compliance with company policies, including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Perform other assignments or projects as directed.

• Associate’s degree or a combination of education and applicable job experience;
  Bachelor's degree preferred.
• 5+ years of relevant quality and/or manufacturing experience in an 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.
• Ability to effectively share information and ideas within and outside the department in written or verbal form; ability to put forth ideas and gain understanding from others.
• Proficiency in 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).

Regularly required to stand, walk, sit, use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch; see, talk, or hear. May occasionally lift and/or move up to 45 pounds. Use hands to finger, handle, or feel objects, tools, or controls to perform repetitive motion job functions. Specific vision abilities required include close vision, color vision, and ability to adjust focus.

Wears personal protective equipment as required.

On‑site at the Barnes Canyon office.

Schedule:

Friday, Saturday, and Sunday from 5:00 a.m. to 5:30 p.m.

The starting base pay range is $22.50 to $24.00 per hour, varying by experience, knowledge, and location. Additional benefits include medical, dental, and vision coverage from the first day, health savings account, flexible savings account, 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day one), 401(k) plan with company match, and an Employee Stock Purchase Plan.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. Candidates are required to complete a pre‑employment screening that includes a drug test (excluding marijuana) and background check, which may review criminal history. Applicants must be authorized to work in the United States; no sponsorship will be provided.

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 welcome applications from a wide range of candidates and selection for roles will be based on individual merit alone.