| Senior Quality Engineer Medical Devices :: Onsite Bellevue WA at Bellevue, Washington, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2672008&uid=4cd65681546c4b7fb5d9e05cc0cf5ad2 From: Praveen Nagar, Vyze inc [email protected] Reply to: [email protected] Job Description - Job ID BXTRJP00026882 Job Title: Senior Quality Engineer Medical Devices Location: Onsite Bellevue WA Contract: 12+ months contract with extension Rate: Open based on exp Job Description Type: Temp-to-hire possible Schedule: 8 AM5 PM PT, Hybrid (3 days onsite) Local preferred; open to remote with some travel Experience: 8+ years in medical device Quality Engineering (hardware + software) Key Responsibilities: Lead quality engineering activities for new hardware/software medical device development, including design control and risk management. Develop and maintain Risk Management File (RMF), dFMEA, pFMEA, hazards analysis, and risk reports. Review/approve Design History File (DHF), design inputs/outputs, verification & validation plans, test protocols, and reports. Provide statistical guidance for design verification, validation, and test method validation. Act as SME for software quality, including code reviews, cybersecurity, software BOM, and AI/cloud-based solutions. Support design transfer, production anomalies, CAPA closure, and quality system updates based on regulations. Qualifications: Strong knowledge of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366. Experience in medical device hardware, software, and electromechanical systems. Skilled with statistical tools (Minitab), Microsoft Office, Adobe Acrobat. ASQ CQE and/or Six Sigma /Black Belt preferred. AI, SaMD, AAMI TIR45, and cloud infrastructure experience a plus. B.S./M.S. in Engineering (biomedical, software, electrical, or related). Keywords: artificial intelligence access management Idaho Washington Senior Quality Engineer Medical Devices :: Onsite Bellevue WA [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2672008&uid=4cd65681546c4b7fb5d9e05cc0cf5ad2 |
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| 03:21 AM 12-Aug-25 |