Nationwide, Qualified Data Systems has an immediate need for several experienced Software Quality Assurance consultants (SQAs). We are looking for SQAs with direct experience in the Medical device, Pharma or Biotech Industries, to join the QDS team on an active project being conducted remotely. The SQAs primary function is providing technical consulting guidance and expertise to customers.
Responsibilities for the SQA role include:
Provide guidance for quality and compliance activities
Development and implementation of System Development Life Cycle Processes from technology acquisition to system retirement.
Lead project teams focused on delivering Governance, Risk, and Compliance services providing hands-on consulting experience to project teams in system selection, acquisition, specification, configuration, design assurance, implementation, integration, and maintenance.
Provide technical evaluations of Enterprise Applications including Embedded Devices, Standalone Applications, Middleware, Databases, Cloud Infrastructure, and IT Networks.
Leads in requirements elicitation and detailed design discussions with software developers, software analysts, R&D, hardware engineers, software architects, program managers and quality/regulatory personnel.
Analyzes business processes using advanced Data Analytics tool
Bachelors’ degree in Electrical Engineering, Computer Engineering, Computer Science, or similar engineering discipline including Software Engineering or Biomedical Engineering
Must possess direct experience within manufacturing, business, or laboratory environments.
Experience in IT Compliance within the regulated Life Sciences is needed.
Must have direct experience with regulatory compliance guidance including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures
Desired experience with Industry guidance including NIST 800-53, IEC 62443, IEC 27001, IEC 29100, IEC 17799, GAMP, GDPR, Data Integrity
Experience with secure software & firmware design, architecture, coding, trusted manufacturing, and trusted supply chains
Experience in designing and performing quality & compliance risk assessments
Certifications desirable: CISA, CRISC, CGEIT, CISSP, GSSP, CSSLP, SSCP, CIPP, CSQE, CQA
Experience with software development methods, secure development lifecycle (SDLC), security-by-design, change management, contingency planning, and disaster recovery
Total Combined Experience: 5+ Years Please do not apply if you have no Software Quality experience. Individuals with no software experience will not be considered.