Smart TechLink Solutions Inc.
Senior QA Engineer (Medical Device Industry)
Smart TechLink Solutions Inc., Bellevue, Washington, us, 98009
Role – Senior Quality Engineering
Location – 220 120th Avenue NE, Bellevue, WA, USA, 98005 (3 Days Onsite)
Type of Hire – Contract/ C2H – Contract
Summary 8 years of progressive Quality Engineering experience in the Medical Device industry with hands‑on support for hardware and software development.
Main Duties and Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams.
Lead 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.
Lead 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.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as SME for software quality and collaborate on code reviews, software security analysis, and the software BOM; lead best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support 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.) and guide triage and remediation efforts.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs related to the design control process.
Support released products, interface with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
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 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.
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.
Thanks & Regards Alamgir Ansari | Technical Recruiter
#J-18808-Ljbffr
Type of Hire – Contract/ C2H – Contract
Summary 8 years of progressive Quality Engineering experience in the Medical Device industry with hands‑on support for hardware and software development.
Main Duties and Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams.
Lead 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.
Lead 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.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as SME for software quality and collaborate on code reviews, software security analysis, and the software BOM; lead best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support 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.) and guide triage and remediation efforts.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs related to the design control process.
Support released products, interface with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
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 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.
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.
Thanks & Regards Alamgir Ansari | Technical Recruiter
#J-18808-Ljbffr