Senior QA Technician – NPI & Validation for Med Devices

PROCEPT BioRobotics

San Jose (CA)

On-site

USD 90,000 - 120,000

Full time

2 days ago

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Job summary

PROCEPT BioRobotics in San Jose, CA, seeks a Senior Quality Assurance Technician to support New Product Introduction (NPI) activities, perform inspections and testing, and ensure products meet design and regulatory requirements. The role emphasizes documentation, cross-functional collaboration with R&D, Manufacturing, and Quality Engineering, and adherence to GDP throughout the product lifecycle.

Ideal candidates will have hands-on experience with inspection equipment and a strong quality

Qualifications

High school diploma or GED with 4+ years in product testing, engineering lab support, or manufacturing in regulated environments.
Experience following written procedures, test protocols, work instructions, and inspection methods.
Experience documenting test results and maintaining GDP-compliant records.
Hands-on experience using basic inspection and measurement equipment (calipers, micrometers, force gauges, multimeters).
Proficiency with Microsoft Office (Excel, Word, Outlook).

Responsibilities

Support prototype builds, design iterations, engineering studies, pilot builds, and product testing.
Prepare, label, track, store, and maintain traceability of test samples.
Set up test fixtures, equipment, and samples per approved procedures.
Verify calibration of test equipment; report issues.
Execute verification and validation protocols, including functional, reliability, and performance testing.
Record conditions and results in GDP-compliant documentation.
Summarize test data for review by Quality Engineering and stakeholders.
Support failure investigations and root cause analysis; reproduce failures and document observations.