Quality Specialist Engineer

Stefanini Group is hiring!Stefanini is looking for Quality Specialist Engineer for Bellevue, WA location (Hybrid work).For quick Apply, please reach out to Tuhin Podder- call: / email: for W2 Candidates only! Hours: 8am-5pm Pacific TimeHybrid work: Local candidate preferred. Will be working with engineers and will need to come to the office on a regular basis 3 days per week or as needed. Open to remote with some travel to site. Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM, lead implementation of best practices for software quality processes.Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.Secondary/Backup Duties and Responsibilities:Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.Own the resolution and timely closure of CAPAs as they relate to the design control process.Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.Support other areas of the Quality System and perform other tasks as defined by Management.

Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non- embedded software.Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.Exceptional verbal and written communication skills and presentation skills.Exceptional attention to detail with the proven ability to wear many hats.Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.Creative problem solver.Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software. Additional Qualifications:Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred. Education and Experience:8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree. Physical Demands and Work Environment:Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers. About Stefanini Group:The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.

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