Quality Control Technician - Bolt Medical : Job Details

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RECRUITERS: DO NOT CONTACT.

Role Description

The Quality Inspector performs incoming inspection, in-process inspections, and final inspections of components and assemblies per control/quality plans. The Quality Inspector will review and approve final release documentation. Performs incoming inspections per control/quality plans for received materials. This role will also complete appropriate quality records within company and GMP guidelines, policies and procedures.

Roles and Responsibilities:

• Inspect incoming or production materials for conformance to engineering drawings, schematics, and specifications; process standards and specifications; and production or process plans.
• Perform incoming test of components. Monitor for conformance to design or test specifications or standards.
• Accept or reject materials or articles; identify and document non-conformance and notify appropriate personnel of potential rejection of items.
• Refer/document unusual inspection problems to supervision, lead or Project Quality Engineer.
• Know using a variety of measuring tools including electrical test sets, multimeter, fixed, limit, plug-gages, steel rules, scales, micrometers, calipers, and surface plate.
• Assist in the writing and updating of inspection procedures, protocol, and checklists.
• Transferring, releasing or quarantining material physically according to inspection status
• Documenting and maintaining inspection and test records
• Understand the importance of product conformity.
• Understand lot numbers and traceability.
• Understand ISO 13485 quality assurance standards and the related documentation in support of.
• Maintains safe and clean work environment by keeping shelves, workstations, etc. neat and complying with procedures, rules and regulations.
• Complete respective paperwork/documentation.

Education:

• Minimum of High School Diploma and two years or more working experience in a relevant, cGMP/FDA regulated industry.

Required Knowledge & Experience:

• Be able to read and understand mechanical drawings and dimensions
• Be able to read and interpret drawing notes and able to understand configuration management (revision control)
• Be able to use basic measuring tools such as calipers, go-no/go gauges, torque wrenches, and others as necessary
• Experience with electrical test sets, multimeter, vision measuring system is a plus
• Experience working with an ERP system and data entry
• Experience with Outlook and MS Office.
• Good communication and organizational skills.
• Must possess good math fundamentals, comprehend written work instructions, and communicate well.
• Knowledge of medical device manufacturing
• Working understanding of GDP and GMP
• Excellent documentation skills, attention to detail and accuracy
• Team player, flexible multitask, good written/oral communicator
• Must be organized and able to coordinate activities with internal departments and outside vendors