Quality Engineer - Trenton, United States - Biotech Partners

Biotech Partners Trenton, United States

2 weeks ago

Description

Job Title:
Quality Engineer - Medical Devices/IVD

Company Overview:
Our company is a leading innovator in the field of medical devices and in vitro diagnostics (IVD). We are dedicated to delivering cutting-edge solutions that improve patient outcomes and enhance healthcare.

Our commitment to quality and excellence drives our success, and we are currently seeking a talented Quality Engineer with a Software focus to join our dynamic team.

Position Overview:

As a Quality Engineer with a Software focus, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices and IVD products.

The ideal candidate will have 1-5 years of experience in the medical device industry, particularly with a strong background in software quality assurance.

The role involves working with technical medical devices that integrate substantial IT/Software components.

Key Responsibilities:
Quality Management System (QMS): Maintain and enhance the QMS, ensuring alignment with industry standards and regulations.

Documentation Review:
Conduct thorough reviews of technical documentation to ensure accuracy, completeness, and compliance with regulatory requirements.

IVDR/MDR Compliance:
Demonstrate expertise in working under In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) guidelines.

Design Project Specifications:

Collaborate with cross-functional teams in the development and review of design project specifications for medical devices, with a strong emphasis on IT/Software components.

Risk Management:
Contribute to the identification, assessment, and mitigation of risks associated with software components in medical devices.

Validation and Verification:
Oversee validation and verification activities for software-related aspects of medical devices, ensuring they meet regulatory and quality standards.

Continuous Improvement:
Actively participate in continuous improvement initiatives, providing recommendations to enhance product quality and compliance processes.

Qualifications:
Bachelor's degree in Engineering, Computer Science, or a related field.

1-5 years of experience in a Quality Engineer role with a focus on software within the medical device or IVD industry.

In-depth knowledge of QMS, IVDR, MDR, and other relevant regulatory requirements.
Experience working on design projects for technical medical devices with significant IT/Software components.
Strong understanding of risk management principles and practices.
Excellent communication and collaboration skills.

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