QA Inspector (hands-on, on-Site, no hybrid) - local to San Jose

Gener8, LLC•San Jose, CA

16h•$23 - $38•Onsite

About The Position

Gener8 is seeking a hands-on QA Inspector for an on-site position in San Jose, CA. The QA Inspector will be responsible for ensuring product quality through the inspection of raw materials, in-process assemblies, mechanical components, and finished goods in accordance with specifications, drawings, and SOPs. This role involves identifying defects, initiating nonconformances, and verifying compliance of manufacturing materials. The inspector will perform visual and dimensional inspections, including CMM-based measurements and verification of BOM callouts and serial number traceability. The position also requires creating Final QC documentation and ensuring products meet release criteria, while supporting Gener8’s ISO 13485 and FDA 21 CFR 820 requirements.

Requirements

High school diploma or equivalent
3 - 5 years inspection experience in medical device or regulated manufacturing.
Experience reading blueprints, engineering drawings, and using metrology tools.
Ability to interpret engineering drawings, specifications, GD&T, and tolerance requirements.
Strong understanding of inspection methods and defect identification.
Familiarity with ISO 13485 and FDA 21 CFR 820 requirements.
Strong documentation accuracy and attention to detail.
Ability to work independently and collaborate with Operations and Quality Engineering.
Basic computer skills

Nice To Haves

Technical training preferred
Technical training in inspection, mechanical measurement, or manufacturing preferred.
Experience with dimensional inspection, GD&T interpretation, or CMM preferred.
Experience with QMS or ERP systems preferred.

Responsibilities

Perform incoming inspection of raw materials and components according to drawings and inspection procedures.
Conduct in-process and final inspection on manufactured products, including verification of correct materials, components, BOM callouts, and revision levels.
Create Certificates of Conformance (CofC) and record serial numbers into the system for traceability.
Follow Work Instructions (WI) and compare BOM callouts to assemblies to confirm correct materials and revision levels.
Inspect parts using calipers, micrometers, pin gauges, height gauges, microscopes, and other metrology devices.
Operate CMM equipment, run programmed inspection routines, and record dimensional results.
Interpret engineering drawings including GD&T requirements and tolerance analysis.
Identify, document, and reject nonconforming materials or products.
Initiate NCRs per procedure and segregate non-conforming items to prevent unintended use.
Issue QCP (Quality Control Pass) or NCR (Quality Control Reject) based on inspection results.
Communicate nonconforming trends or recurring issues to Quality Engineering, Production, and Supervisors.
Maintain accurate inspection records, logs, travelers, CofCs, and traceability documentation.
Enter inspection results, serial numbers, NCRs, and CofC information into QMS/ERP systems.
Verify chemicals, adhesives, and time-sensitive materials are within expiration date; perform monthly checks.
Ensure all inspection activities comply with Good Documentation Practices (GDP).
Communicate inspection findings clearly to Operators, Production Leads, and Quality Engineering.
Support MRB investigations by providing dimensional data and inspection findings.
Provide feedback that supports root cause analysis and continuous improvement.
Ensure the inspection area is organized, controlled, and audit-ready.
Assist with inspection-related training as needed.
Perform additional quality duties as assigned.