Quality Technician III
About The Position
The Quality technician will review device history records and approve final release documentation. This role will also complete appropriate quality records within company GMP (Good Manufacturing Process) and GDP (Good Documentation Practice) guidelines, policies and procedures. The Quality Technician performs inspection, in-process inspections, and final inspections, review of device history records of manufacturing/batch records per control/quality plans The Quality Technician will keep track of Non-Conformance material and documentation, place or remove required label of the product/materials involved in the non-conformance.
Requirements
- Be able to identify GDP errors
- Be able to apply and remove material labels.
- 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 records use within 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
- Experience assisting regulatory inspections and/or audit
- Minimum of High School Diploma or AA degree in a scientific discipline and two years or more working experience in a relevant, cGMP/FDA regulated industry.
Responsibilities
- Knowledge handling and reviewing device history records is a key responsibility in this position.
- Review incoming or production documentation for conformance that may include reworks, test data, engineering drawings, schematics, and specifications; process standards and specifications; and production or process plans.
- Knowledge handling Non-conformance documentation for manufacturing batch records and identifying GDP (Good Documentation Procedures) errors.
- Accept or reject device history records or first article inspection; identify and document non-conformance and notify appropriate personnel of potential rejection/correction of items.
- Refer/document unusual inspection problems to supervision, lead or Project Quality Engineer.
- Knowledge 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
