On-Site QA Specialist - Medical Devices

Tandem Diabetes Care; San Diego (CA); On-site; USD 30,000 - 33,000; Full time

Job summary

Tandem Diabetes Care is seeking a Quality Assurance Associate for on-site manufacturing QA in San Diego. The role conducts inspection and release of goods during manufacturing according to QTPs & SOPs, compiling data for test documentation and supporting report preparation.

The position is temporary, with benefits during the assignment and potential for conversion. Minimum A.S. degree plus 5+ years in QA/manufacturing in a FDA-regulated setting are required.

Qualifications

• Associate’s degree or combination of education and applicable job experience.
• Bachelor’s degree preferred.
• 5+ 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.
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Proficient experience with MS Office suite (Word, Excel, Outlook).

Responsibilities

• 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.

Skills

Quality & manufacturing experience

GMP knowledge

QC testing

QSRs

Document review

In-process inspection

Project coordination

Communication

Cross-functional collaboration

MS Office

Education

Associate’s degree

Bachelor’s degree preferred

Job description

Tandem Diabetes Care is seeking a Quality Assurance Associate for on-site manufacturing QA in San Diego. The role conducts inspection and release of goods during manufacturing according to QTPs & SOPs, compiling data for test documentation and supporting report preparation.

The position is temporary, with benefits during the assignment and potential for conversion. Minimum A.S. degree plus 5+ years in QA/manufacturing in a FDA-regulated setting are required.