Quality Engineer I
Location
medina-wa
Level
Entry-Level
Department
MedTech
Type
Salary
$67,000 - $90,000
Job Description
Posted on:
2025-05-20
Responsibilities
- Ensure compliance with the OAI Quality Management System.
- Support preparation of change orders and maintenance of Quality Management System documentation.
- Coordinate training and assist in developing training materials.
- Investigate identified nonconformances and generate Non-conformance Reports (NCRs).
- Complete Corrective Action and Preventive Action (CAPA) tasks.
- Meet Key Performance Indicator (KPI) targets for quality metrics.
- Assist in hosting internal and external audits.
Job Requirements
- Bachelor's degree or equivalent in an engineering discipline (Biomedical Engineering preferred).
- Experience with risk management and problem-solving.
- Proficiency in Microsoft Office Suite.
- Strong verbal and written communication skills.
- Minimum 2 years of experience in an engineering position, preferably in Quality Systems Engineering.
- Knowledge of medical device regulations such as 21 CFR Part 820 and ISO 13485 preferred.
- Familiarity with statistical analysis and problem-solving tools.
