Serve as a subject-matter expert on product development related design control SOPs (Standard Operating Procedures, work instructions, work templates and training).
Support verification and validation protocol execution, perform data review, and assist in deviation resolution process by using knowledge of deviation management and Quality Implication and Corrective and Preventive Actions (CAPA) to ensure continuous improvement during development, manufacturing, and product release.
Generate, review, and approve verification and validation protocols for Medical device applications, including IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) using experience with system review, verification and validation and knowledge of the medical device development and manufacturing domain.
Analyze business, compliance, data Integrity and technical/operational requirements for Medical device and Pharmaceutical Software as a Service product, to support technical and product leaders to create quality management systems (QMS) consistent with compliance requirements.
Act as a bridge between cross-functional team members and quality compliance to identify gaps and help resolve questions and open issues for low risk SaaS and medical devices.
Author, review, and finalize software test and design verification and validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Reports, and also help maintaining SOPs and work instructions.
Ensure product verification and validation and program deliverables packages are complete as required for audits and regulatory inspections.
Assess change control and discrepancy events for system verification, validation systems and automation systems. Work with subject matter experts through quality risk management process and prepare risk management reports documenting system risks, applicable remediation, risk reduction, and critical controls.
Will also contribute to the Software Development Lifecycle (SDLC) process engineering. This will include maintaining SOPs, work instructions, training documents and tools to support the process (Jira/Enzyme, Zephyr/ Aha!). Strong interest and knowledge in process and tools development for regulated software development is needed.
A medical device or healthcare software background with experience working in a regulated environment is required. Working effectively with the Quality System, Regulatory and Software Engineering functions will be a key success factor. Ensure the applications developed are compliant with FDA (Food and Drug Administration) regulations such as 21 CFR part11, 21 CFR part820 and ISO regulations such as ISO 13485 (Standard for medical devices).
Bachelor's degree Biomedical Engineering, Computer Science, Technical writing, or a related life science field, and 5 years of post-baccalaureate and progressive in job offered or as Verification & Validation Test Engineer, Validation Analyst, or System Analyst.
Specialized Experience: Must have 3 years of experience with each of the following:
Medical,. pharma, Bio Science or related Industry experience
Computer system validation
FDA and ISO standards and regulations
Agile SW development
System verification and validation experience
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering
Hoffmann-La Roche Ltd