Quality Technician III

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

At Boston Scientific, we offer the opportunity to harness all that is within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we help you advance your skills and career. Here, you’ll be supported in progressing—whatever your ambitions.

The Quality Technician reviews device history records and approves final release documentation. This role also completes appropriate quality records within company GMP (Good Manufacturing Process) and GDP (Good Documentation Practice) guidelines, policies and procedures. The Technician performs inspections— in‑process and final inspections— reviews device history records of manufacturing/batch records per control/quality plans, keeps track of non‑conformance material and documentation, and places or removes required labels on the product/materials involved in non‑conformance.

This is an on‑site role based at our facility. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Handling and reviewing device history records.
• Reviewing 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.
• Handling non‑conformance documentation for manufacturing batch records and identifying GDP errors.
• Accepting or rejecting device history records or first article inspection; identifying and documenting non‑conformance and notifying appropriate personnel of potential rejection/correction of items.
• Referencing or documenting unusual inspection problems to supervision, lead or Project Quality Engineer.
• Using a variety of measuring tools including electrical test sets, multimeter, fixed, limit, plug‑gauges, steel rules, scales, micrometers, calipers and surface plate.
• Assisting in the writing and updating of inspection procedures, protocols and checklists.
• Transferring, releasing or quarantining material physically according to inspection status.
• Documenting and maintaining inspection and test records.
• Understanding the importance of product conformity.
• Understanding lot numbers and traceability.
• Understanding ISO 13485 quality assurance standards and related documentation.
• Maintaining a safe and clean work environment by keeping shelves, workstations, etc. neat and complying with procedures, rules and regulations.
• Completing respective paperwork/documentation.

Required qualifications:

• Identify GDP errors.
• Apply and remove material labels.
• Read and understand mechanical drawings and dimensions.
• Read and interpret drawing notes and understand configuration management (revision control).
• 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.
• 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.
• 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.

The above descriptions are intended to describe the general nature and level of work being…