| Senior QA Testing -Medical devices at Remote, Remote, USA |
| Email: [email protected] |
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Senior QA Testing Leader Location : 100% Remote medical devices experience Must Job Description Experience with QA of Next Generation Sequencing (NGS) Bioinformatics pipeline. Ideally familiarity with the Bioinformatics pipeline as part of medical devices/assays. Preferentially in the space of Cancer Diagnostics. Experience with NGS assays, ideally for diagnostics products NSG Assays , Should have experience submitting documentation and reviewing the technical writing for forms submission to Clearance authorities (FDA, EMA-MDR) Related experience on Software as a medical device, or otherwise, software that is active medical device or active device for diagnosis is required a. 1) Senior QA Testing Leader ~7-10 years, FDA software as a med device clearance (e.g. 510k), EU, IMDRF definitional bodies, other regional. US East Coast or Nearshore possible i. Should have experience submitting documentation and reviewing the technical writing for forms submission to Clearance authorities (FDA, EMA-MDR) ii. Related experience on Software as a medical device, or otherwise, software that is active medical device or active device for diagnosis is required iii. QA Test toolkit, manual and automated testing 1. Functionality Testing: Evaluates how the device performs under various scenarios. 2. Device Verification Testing: Ensures the device meets specifications. 3. Device Validation Testing: Verifies the device's safety and effectiveness. 4. Device Compatibility & Error Handling Testing: Ensures compatibility and handles errors. 5. Automated Testing: Uses automated tools for testing. 6. White-Box Testing: Examines internal workings of the software. iv. Quality Engineering mindset with experience interacting with clients Quality Management System or other guidelines v. Focus on performance and experience for generating qualified output data vi. Experience and background with Bioinformatics or informatics software solutions in the field of medical diagnostics vii. Familiarity with open source bioinformatics software or other toolkits for developers, researchers and scientists https://en.wikipedia.org/wiki/List_of_open-source_bioinformatics_software -- sai krishna Account Manager [email protected] linkedin: https://www.linkedin.com/in/sai-krishna-putta-845518232/ Email is the Best way To reach me . -- Keywords: quality analyst information technology Senior QA Testing -Medical devices [email protected] |
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| 02:13 AM 11-Mar-25 |