What are the responsibilities and job description for the QA Inspector (hands-on, on-Site) position at Gener8, LLC?
Job Title: | QA Inspector |
Reporting to: | Sr. Manager, SW QA and Compliance |
Location: | San Jose, CA |
Job Site: | On-Site |
Job Description Revision Date: | Form 00004 - Rev. B |
About us:
Gener8 is an innovative tech company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica. We know what it takes to be a key partner in the life science and medical device industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering and software design services and manufacturing complex instruments and consumables. Our customers are striving for breakthroughs in medical research and diagnostic applications as well as surgical devices that help scientists and medical professionals understand and diagnose diseases and improve patient treatment outcomes.
Purpose
Ensures product quality through inspection of raw materials, in-process assemblies, mechanical components, and finished goods in accordance with specifications, drawings, and SOPs. Identifies defects, initiates nonconformances, and verifies compliance of manufacturing materials such as chemicals and adhesives. Performs visual and dimensional inspection including CMM-based measurements and verification of BOM callouts and serial number traceability. Creates Final QC documentation and ensures products meet release criteria. Supports Gener8’s ISO 13485 and FDA 21 CFR 820 requirements.
SPECIFIC DUTIES AND RESPONSIBILITIES
- Incoming, In-Process, and Final Inspection:
- 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.
- Dimensional Inspection & Measurement Tools:
- 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.
- Nonconformance Identification & Documentation:
- 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.
- 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.
- Documentation, Traceability, and System Records:
- 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).
- Support for Operations, Engineering, and MRB:
- 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.
Supervisory responsibilities
- None
Education
- High school diploma or equivalent; technical training preferred.
- Technical training in inspection, mechanical measurement, or manufacturing preferred.
Experience
- 3 - 5 years inspection experience in medical device or regulated manufacturing.
- Experience reading blueprints, engineering drawings, and using metrology tools.
- Experience with dimensional inspection, GD&T interpretation, or CMM preferred.
Knowledge, Skills and TraininG
- 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; experience with QMS or ERP systems preferred.
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Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Salary : $23 - $38