Diverse Lynx
Engineer - Software Quality Assurance & Validation (Medical Devices)
Diverse Lynx, Santa Clara, California, us, 95053
Role- Engineer - Software Quality Assurance & Validation (Medical Devices)
Location- Santa Clara, CA onsite
Job Type- Contract
Role Description:
We are seeking a highly skilled and experienced Engineer to join our team, focusing on the quality assurance and validation of non-product software used in medical device development. The successful candidate will be instrumental in ensuring that our software systems adhere to stringent regulatory standards and industry best practices, contributing directly to the safety and efficacy of our medical devices.
Key Responsibilities:
Develop, implement, and maintain robust software quality assurance processes specifically for non-product software used in the medical device development lifecycle. Ensure strict adherence to relevant regulatory standards, including FDA regulations, ISO 13485, and IEC 62304, as well as industry best practices for non-product software. Provide comprehensive support during audits and inspections conducted by regulatory bodies, ensuring all non-product software systems meet required quality and documentation standards. Verify that all computerized systems are appropriately validated, including assessing the applicability and criticality of GxP and 21 CFR Part 11 requirements. Create and meticulously review a range of validation deliverables, which include but are not limited to:
Requirement Specifications (User, Functional) Validation Plans Qualification Protocols (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution Traceability Matrices Periodic Review documentation System Retirement/Decommissioning documentation
Execute dry runs and test protocol runs to ensure accuracy and completeness. Conduct periodic reviews of systems to confirm their validated state and initiate appropriate corrective actions as needed. Oversee and perform the system retirement/decommissioning process for systems no longer in business use. Collaborate closely with software development and IT teams to establish and promote best practices for quality and compliance in all software-related activities. Offer expert guidance and support on quality assurance processes for non-product software, fostering robust software management throughout its lifecycle. Champion continuous improvement initiatives within software development processes, ensuring seamless alignment with the company's overarching quality management system. Competencies:
EIS: Medical Device & Regulations Experience (Years):
4-6 years Essential Skills:
Minimum of a Bachelor's Degree in Engineering, Science, or a related technical field. Minimum of 4-5 years of hands-on experience in software quality assurance or software validation, with a strong preference for experience within the medical device industry. Demonstrated strong understanding of quality standards and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and IEC 62304. Proven experience with non-product software validation, encompassing tools used for development, testing, and maintenance. Desirable Skills:
Good knowledge and practical experience with Computer System Validation (CSV) activities, including but not limited to:
GxP and 21 CFR Part 11 applicability/criticality assessment. Identification, preparation, and review of validation deliverables such as Requirements, Plans, Protocols, Test specifications, Reports, Traceability Matrices, etc. Execution of Dry/Test protocols. Conducting Periodic Reviews of systems. Performing System Retirement for systems no longer in business.
Understanding of Medical Device Quality and Compliance principles. Good knowledge of GxP, GAMP, and 21 CFR Part 11 guidelines. Working experience with Product Lifecycle Management (PLM) tools. Sound knowledge of computer system development lifecycles. Knowledge of JIRA, JAMA software, and test automation is a plus.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Develop, implement, and maintain robust software quality assurance processes specifically for non-product software used in the medical device development lifecycle. Ensure strict adherence to relevant regulatory standards, including FDA regulations, ISO 13485, and IEC 62304, as well as industry best practices for non-product software. Provide comprehensive support during audits and inspections conducted by regulatory bodies, ensuring all non-product software systems meet required quality and documentation standards. Verify that all computerized systems are appropriately validated, including assessing the applicability and criticality of GxP and 21 CFR Part 11 requirements. Create and meticulously review a range of validation deliverables, which include but are not limited to:
Requirement Specifications (User, Functional) Validation Plans Qualification Protocols (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution Traceability Matrices Periodic Review documentation System Retirement/Decommissioning documentation
Execute dry runs and test protocol runs to ensure accuracy and completeness. Conduct periodic reviews of systems to confirm their validated state and initiate appropriate corrective actions as needed. Oversee and perform the system retirement/decommissioning process for systems no longer in business use. Collaborate closely with software development and IT teams to establish and promote best practices for quality and compliance in all software-related activities. Offer expert guidance and support on quality assurance processes for non-product software, fostering robust software management throughout its lifecycle. Champion continuous improvement initiatives within software development processes, ensuring seamless alignment with the company's overarching quality management system. Competencies:
EIS: Medical Device & Regulations Experience (Years):
4-6 years Essential Skills:
Minimum of a Bachelor's Degree in Engineering, Science, or a related technical field. Minimum of 4-5 years of hands-on experience in software quality assurance or software validation, with a strong preference for experience within the medical device industry. Demonstrated strong understanding of quality standards and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and IEC 62304. Proven experience with non-product software validation, encompassing tools used for development, testing, and maintenance. Desirable Skills:
Good knowledge and practical experience with Computer System Validation (CSV) activities, including but not limited to:
GxP and 21 CFR Part 11 applicability/criticality assessment. Identification, preparation, and review of validation deliverables such as Requirements, Plans, Protocols, Test specifications, Reports, Traceability Matrices, etc. Execution of Dry/Test protocols. Conducting Periodic Reviews of systems. Performing System Retirement for systems no longer in business.
Understanding of Medical Device Quality and Compliance principles. Good knowledge of GxP, GAMP, and 21 CFR Part 11 guidelines. Working experience with Product Lifecycle Management (PLM) tools. Sound knowledge of computer system development lifecycles. Knowledge of JIRA, JAMA software, and test automation is a plus.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.