Overview
On Site
Full Time
Skills
Medical Devices
Regulatory Compliance
Functional Testing
Documentation
GDP
Mechanical Engineering
Testing
Data Acquisition
ISO 13485
Job Details
Summary :
Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards.
Roles & Responsibilities :
Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards.
Roles & Responsibilities :
- Prepare test samples and fixtures for mechanical and functional testing.
- Execute tests and document results per Good Documentation Practices (GDP).Generate Test Reports for inclusion in the Design History File (DHF).
- Coordinate with cross-functional teams to ensure timely completion of testing activities.
- Hands-on experience with mechanical testing and data acquisition systems.
- bility to interpret engineering drawings and specifications.
- Familiarity with ISO 13485 and FDA QSR requirements preferred.
- Experience Required 2 - 4 years.
- Develop Test Protocols aligned with design verification plans and regulatory requirements.
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