QA Inspector (hands-on, on-Site, no hybrid) - local to San Jose at Gener8, LLC

San Jose, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

37.91

Posted On

15 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Dimensional Inspection, GD&T Interpretation, CMM Operation, Metrology Tools, Blueprint Reading, ISO 13485 Compliance, FDA 21 CFR 820, Nonconformance Reporting, Good Documentation Practices, Quality Control Inspection, BOM Verification, Traceability Management, QMS/ERP Systems, Tolerance Analysis, Root Cause Analysis, Medical Device Manufacturing

Industry

Hospitals and Health Care

Description

Job Title: QA Inspector, (hands-on, on-Site, no hybrid) - local to San Jose 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. * Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status. * We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration. 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.

Responsibilities

Ensures product quality by performing incoming, in-process, and final inspections of raw materials and finished goods using metrology tools and CMM equipment. Documents nonconformances, maintains traceability records, and ensures compliance with ISO 13485 and FDA regulations.