Quality Engineer
Location
Santa Clara, CA
Level
Mid-Level
Department
MedTech
Type
Salary
$79,000 - $139,000
Job Description
Posted on:
2025-09-10
Responsibilities
- Plans, executes, and documents test method validations for inspection methods.
- Supports receiving inspections and in-house manufacturing inspections.
- Manages equipment/tooling logistics and documentation.
- Executes non-conformance reports and prepares associated metrics.
- Ensures compliance with quality systems across Abbott sites.
- Maintains inspection procedures and selects appropriate testing equipment.
- Identifies opportunities for continuous improvement in quality processes.
Job Requirements
- Bachelor’s degree in Engineering or related field.
- 2-3 years of experience in Quality Assurance/Quality Engineering in medical devices or pharmaceuticals.
- Knowledge in test method validations and statistical analyses.
- Familiarity with regulations (21 CFR 820, FDA, 13485, 14971).
- Strong written and verbal communication skills.
- Ability to work independently and as part of a team.
- Experience with equipment/tooling management and audits is a plus.
