Incoming & Manufacturing Quality Technician

The Incoming & Manufacturing Quality Technician is responsible for ensuring the quality and compliance of incoming materials, manufacturing processes, and production documentation in support of medical device manufacturing. The role performs incoming inspections, in-process quality inspections, documentation review, equipment and calibration support, and nonconformance processing to ensure products meet company, regulatory, and customer requirements.

Responsibilities

Perform incoming inspection of purchased materials, components, and assemblies using approved inspection procedures and sampling plans; Review supplier documentation, engineering drawings, specifications, and acceptance criteria; Conduct visual, dimensional, and functional inspections using calibrated inspection equipment; Support manufacturing through in-process and in-line inspections to verify compliance with approved procedures and quality standards; Review Device History Records (DHRs), travelers, Manufacturing Process Instructions (MPIs), and related production documentation for accuracy and completeness; Identify, document, and segregate nonconforming materials; initiate and support Nonconformance Reports (NCMRs) and Material Review Board (MRB) activities; Coordinate equipment calibration, preventive maintenance, and equipment status while maintaining calibration records; Support product release activities, rework verification, engineering builds, and continuous improvement initiatives; Ensure compliance with FDA QMSR (21 CFR Part 820), ISO 13485, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP); Collaborate with Manufacturing, Engineering, Supply Chain, Supplier Quality, and Regulatory Affairs to resolve quality issues and support production; Fulfill any other duties as assigned

Requirements

Minimum 2+ years of quality inspection experience in a regulated manufacturing environment; Working knowledge of common inspection tools; Experience working with MS Office and Excel or Google Docs and Sheets; Ability to read engineering drawings for inspection/acceptance requirements and use precision measuring equipment; Knowledge of ISO 13485, FDA QMSR, GDP, GMP, and AQL sampling; Experience with eQMS and ERP systems; Process-oriented with the ability to plan and perform work; Able to work in a fast-paced production environment; Ability to lift and handle objects up to 20 pounds

Nice to have

Experience in medical device manufacturing preferred