| Software Validation Engineer, Remote at Remote, Remote, USA |
| Email: [email protected] |
| From: yogesh, StellentIT [email protected] Reply to: [email protected] Software Validation Engineer Location: Remote Interview: Phone + Skype Job description: Supporting the organization by identifying and delivering operational improvements using (new) technology and data. This in the context of our niche and highly regulated quality and operational environment, and the emerging Digital Health market. Working as the technical leader who builds, maintains, and enables computer systems validation and assurance related to engineering activities for all product lines. Leverage expertise in computer system validation and assurance to direct an assurance and validation program that aligns with global regulatory requirements. Actively bring recommendations for harmonization and optimization across business processes and create oversight of the existing technology landscape. Understand the opportunities for digitization utilizing new technologies and regulations on Cloud computing and Computer Software Assurance. Responsibilities: You are responsible for managing a validation program that aligns with global regulation requirements, defining procedures for computer system validation and assurance, and drive decisions around the direction of the company on the subject matter. Lead software validation implementation and any additional QA requirements through effective planning of set up, design and testing. Design, Create, Execute and Approve Software Validation Protocols for Quality Related Software, Engineering Tooling and Laboratory Equipment, including a full software lifecycle that concentrates on the creation of software requirements, software hazard analysis and software testing. Communicate with all engineering departments and perform ongoing research on company tooling to assure that all devices are always maintained in a validated state for 3rd party audit and quality compliance. Assist QA management in response to Customer or Regulated Body Audits in all findings related to software quality or security. Create Software Validation lifecycle documents that are included in submissions to global regulatory agencies. Contributes to the assessment of requirements and documentation of software solutions Contribute to the harmonization and optimization of systems and processes by studying current practices and designing recommendations, including Cloud Computing and Computer Software Assurance. Translate business requirements, both internal and external, into functional requirements in a clear manner that is comprehensible to business and IT stakeholders. Promote data integrity and alignment across the business functions and systems. Act as Business SME (Subject Matter Expert) for our core Quality and Manufacturing Systems, as well act as a trusted advisor in related digital optimization programs. This in the context of our niche and highly regulated quality and operational environment. Requirement: BS Degree in Software Engineering, Biomedical Engineering, or Computer Science Minimum of 7 years Software Quality Engineering experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry Deep understanding of quality risk-management concepts In-depth understanding of industry accepted software development and validation life cycle programs and related to IT controls Fluid collaboration skills across business, digital, and external vendors Very good knowledge of IT systems, preferably in the Engineering Environment Demonstrated ability to evaluate, develop and implement Software QA processes and procedures Demonstrated ability to manage large scale validation projects. Demonstrated ability to Design, create, and execute Software Validations for Manufacturing and Quality tooling Experience with ISO 9001, or ISO 13485, or 21 CFR 820 a plus Familiar with emerging trends like Cloud Computing, Software Assurance and Data Analytics Knowledge of master data management principles Proven experience with business process analysis Keywords: quality analyst information technology |
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| Tue Feb 28 02:07:00 UTC 2023 |