Quality Technician I – Medical Device Inspection (Onsite)

Boston Scientific; Carlsbad (TX); On-site; USD 39,000 - 67,000; Full time

Job summary

Boston Scientific is seeking a Quality Technician to review device history records, approve final release documentation, and perform inspections in line with GMP/GDP guidelines. The role covers in-process, first article, and final inspections, plus handling non-conformances and labeling decisions.

The ideal candidate will read mechanical drawings, use various measuring tools, and maintain accurate inspection records while supporting regulatory readiness and product conformity onsite.

Qualifications

• Experience in a cGMP/FDA regulated environment is required or preferred.
• Ability to identify GDP errors and apply GDP procedures.
• Ability to read and interpret mechanical drawings and specifications.
• Strong documentation and recordkeeping skills with attention to detail.
• Good math fundamentals and clear written/oral communication.

Responsibilities

• Review device history records and approve final release documentation.
• Perform in-process and final inspections according to control/quality plans.
• Track non-conformance material and document labeling actions.
• Accept or reject device history records or first article inspection; document non-conformances.
• Refer unusual inspection problems to supervision or project quality engineer.
• Use measuring tools (calipers, go/no-go gauges, torque wrenches, etc.).
• Assist in writing/updating inspection procedures, protocols, and checklists.
• Transfer, release or quarantine material per inspection status.
• Document and maintain inspection/test records and ensure traceability.

Skills

GDP/GMP knowledge

Documentation & recordkeeping

Reading mechanical drawings

Communication & teamwork

Mathematical fundamentals

Education

High School Diploma or AA degree

Tools

ERP system

Outlook

MS Office

Calipers

Micrometers

Vision measuring system

Job description

Boston Scientific is seeking a Quality Technician to review device history records, approve final release documentation, and perform inspections in line with GMP/GDP guidelines. The role covers in-process, first article, and final inspections, plus handling non-conformances and labeling decisions.

The ideal candidate will read mechanical drawings, use various measuring tools, and maintain accurate inspection records while supporting regulatory readiness and product conformity onsite.