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Quality Engineer-Medical Device Software - Trenton, United States - Scientific Search
Description
Quality Engineer Medical Device SoftwareLocation:
Warren, NJ Hyrbid
Summary:
Step into the role of Quality Engineer at a global leader in specialized diagnostics and medical devices. This pivotal position focuses on Software as a Medical Device (SAMD), ensuring all software complies with critical regulations. If you have expertise in quality assurance within the medical device sector, particularly IVD, your skills are in demand. Join us and contribute to maintaining the highest standards in healthcare technology and patient safety.
Why You Should Apply
Become a subject matter expert in a rapidly growing, family-owned global company with a presence in over 100 territories.
Oversee significant projects from concept to completion, ensuring compliance with GXP systems.
Collaborate cross-functionally with dynamic teams to manage and improve software quality and compliance.
Engage in risk management practices to optimize manufacturing operations and software development.
Competitive compensation and opportunities for professional growth.
What You'll Be Doing:
Review software revision documentation and lead user acceptance and software qualification testing.
Lead cross-functional teams in delivering system-based projects and process improvements.
Support regulatory teams by managing documentation for IVDs, ensuring compliance with international standards.
Monitor and analyze GXP system metrics, identifying trends and areas for improvement.
Maintain and update Design History Files and technical documentation as needed.
About You:
Bachelor's degree in Biomedical Engineering, Biology, Chemistry, Engineering, or a related field. Required
Have at least five years of quality assurance experience in the pharmaceutical or medical device industry, with specific expertise in SAMD.
(software as a medical Device)Familiar with regulatory standards like ISO 13485, 21 CFR Part 820, and MDR/IVDR regulations.
CQE certification is preferred but not required.
How To Apply
We'd love to see your resume, but we don't need it to have a conversation. Send us an email to and tell me why you're interested. Or, feel free to email your resume. Please include Job#18681.
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