Boston Scientific · 3 hours ago
Quality Technician I - 2nd Shift
Boston Scientific is a leader in medical science committed to advancing science for life. The Quality Technician will perform inspections and manage documentation related to device history records, ensuring compliance with quality standards and procedures.
Health CareMedicalMedical Device
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 engineering drawings, schematics, and specifications; process standards and specifications; and production or process plans (IPC-A-610 certification is recommended)
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
Qualification
Required
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
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
Preferred
IPC-A-610 certification is recommended
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Recent News
2026-01-24
2026-01-23
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