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    Quality Engineer - New Jersey, United States - Biotech Partners

    Biotech Partners
    Biotech Partners New Jersey, United States

    3 weeks ago

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    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:

    1. Quality Management System (QMS): Maintain and enhance the QMS, ensuring alignment with industry standards and regulations.
    2. Documentation Review: Conduct thorough reviews of technical documentation to ensure accuracy, completeness, and compliance with regulatory requirements.
    3. IVDR/MDR Compliance: Demonstrate expertise in working under In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) guidelines.
    4. 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.
    5. Risk Management: Contribute to the identification, assessment, and mitigation of risks associated with software components in medical devices.
    6. Validation and Verification: Oversee validation and verification activities for software-related aspects of medical devices, ensuring they meet regulatory and quality standards.
    7. 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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