Quality Control Technician

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

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