Katalyst CRO
Overview
Quality Assurance Engineer
role at
Katalyst CRO . Location: Palo Alto, CA Compensation: $160,000.00$180,000.00 Responsibilities Quality Engineering Support for product software design controls; implement and facilitate product risk management planning as needed; facilitate and participate in design reviews; develop quality engineering deliverables and ensure the Design History File (DHF) is updated as necessary. Contribute to the documentation of quality systems and programs in training, change management, validation, design controls (including product verification and validation), CAPA for design issues, and documentation control to ensure compliance with FDA and regulatory requirements. Serve as the point of contact for assigned programs and provide coaching and mentoring to project managers and product development teams on the product development process and design controls (e.g., risk assessment). Review and provide feedback on product documentation to support the product development process. Participate in technical or specialty design reviews for product development or act as QA representative in the change management process. Assist in developing and delivering training programs (e.g., change control, risk analysis, Design Controls). Prepare for and support regulatory inspections/audits (ISO, MDSAP, etc.), investigations, and inquiries regarding product design quality; support corporate/internal design control audits. Participate in CAPA activities, including investigations, effectiveness checks, root-cause analysis, and implementation of corrective actions and preventive measures. Serve as QA subject matter expert for cross-functional development teams; facilitate risk management activities and provide guidance on the strategy and content of requirements and specifications; provide strategies and approvals for verification methodologies, configuration management, validation and regression testing approaches.
Requirements
10+ years directly employed in R&D Quality Assurance of medical devices. Minimum ten years of experience in a related industry regulated by FDA and/or ISO. Competence in software development processes and in the selection and use of Quality Engineering tools, techniques, and processes. Knowledge and interpretation of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, IVDR, MDSAP, etc.). Effective written and oral communication skills to interact across all levels of the organization. Experience with Microsoft Office (Word, Excel, etc.). Desirable certifications: CQE, CQA, CSQE, CRE, BCA, or Six Sigma Black Belt.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Quality Assurance Engineer
role at
Katalyst CRO . Location: Palo Alto, CA Compensation: $160,000.00$180,000.00 Responsibilities Quality Engineering Support for product software design controls; implement and facilitate product risk management planning as needed; facilitate and participate in design reviews; develop quality engineering deliverables and ensure the Design History File (DHF) is updated as necessary. Contribute to the documentation of quality systems and programs in training, change management, validation, design controls (including product verification and validation), CAPA for design issues, and documentation control to ensure compliance with FDA and regulatory requirements. Serve as the point of contact for assigned programs and provide coaching and mentoring to project managers and product development teams on the product development process and design controls (e.g., risk assessment). Review and provide feedback on product documentation to support the product development process. Participate in technical or specialty design reviews for product development or act as QA representative in the change management process. Assist in developing and delivering training programs (e.g., change control, risk analysis, Design Controls). Prepare for and support regulatory inspections/audits (ISO, MDSAP, etc.), investigations, and inquiries regarding product design quality; support corporate/internal design control audits. Participate in CAPA activities, including investigations, effectiveness checks, root-cause analysis, and implementation of corrective actions and preventive measures. Serve as QA subject matter expert for cross-functional development teams; facilitate risk management activities and provide guidance on the strategy and content of requirements and specifications; provide strategies and approvals for verification methodologies, configuration management, validation and regression testing approaches.
Requirements
10+ years directly employed in R&D Quality Assurance of medical devices. Minimum ten years of experience in a related industry regulated by FDA and/or ISO. Competence in software development processes and in the selection and use of Quality Engineering tools, techniques, and processes. Knowledge and interpretation of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, IVDR, MDSAP, etc.). Effective written and oral communication skills to interact across all levels of the organization. Experience with Microsoft Office (Word, Excel, etc.). Desirable certifications: CQE, CQA, CSQE, CRE, BCA, or Six Sigma Black Belt.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr