Neurita Salva
San Diego
Summary
Senior Quality Engineer with 15 years in regulated medical devices and in vitro diagnostics. Expert in design controls, risk management, and verification & validation. Demonstrates strong project management and technical documentation skills, supporting audits and product launches. Collaborates effectively across teams, enhancing lifecycle risk management and mentoring junior engineers.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Design Quality Engineer III
Hologic, Inc
San Diego
03.2022 - 01.2026
- Provided Quality Engineering support for product design and development from feasibility through transfer into commercialization and post-launch surveillance and change management activities
- Worked with product development teams to ensure appropriate design control measures are applied during development and transfer of Hologic products
- Collaborated with new product development teams to ensure compliance with design controls.
- Assessed design changes from a systems perspective, identifying risks, delivering design mitigations, and evaluating the effectiveness of risk control measures
- Reviewed and approved design control and risk management documentation, ensuring compliance with established requirements and supporting effective risk management activities
- Guided core team members and key stakeholders on quality systems requirements and design controls, fostering understanding and adherence to regulatory standards
- Participated in project teams to review and update user requirements, product specs, plans, verification and validation studies, risk management file and other relevant deliverables
- Supported FMEAs and other risk assessment processes and documentation
- Led non-conformance and CAPA initiatives, facilitating alignment with NCE and CAPA processes to enhance product quality and compliance
- Supported regulatory inspections and audits associated with design control documentation
- Supported research and development teams with platform or systems reliability testing and characterization with both hardware and software
- Mentored junior Quality Engineers
Staff Scientist
Invivoscribe
San Diego
12.2020 - 03.2022
- Led development and validation of blood cancer companion diagnostics, collaborating with cross-functional teams and stakeholders to ensure project alignment and success
- Independently designed and executed experiments, generating data to advance product development initiatives
- Collaborated with manufacturing, quality, regulatory, and sales & marketing to streamline development, transfer, submission, and commercialization of IVS products
- Developed experimental designs, protocols, and reports that met established guidelines, contributing to regulatory compliance and research integrity
- Conducted independent data analysis utilizing appropriate software tools
- Reviewed peers’ laboratory notebooks, experimental designs, draft protocols, and reports to ensure accuracy and regulatory compliance
- Authored and reviewed documentation in compliance with the IVS Quality Management System and applicable regulations
- Maintained comprehensive laboratory records (physical and electronic) in accordance with good documentation practices
- Ensured the accuracy and completeness of auditable documents
- Contributed to project timelines and budgets
Operations Senior Scientist
Hologic, Inc
San Diego
08.2019 - 12.2020
- Led the stability team to oversee annual monitoring and shelf-life studies for 40 marketed assays and newly transferred developed assays.
- Planned and supported stability testing and scheduling for on-market products, ensuring compliance and product integrity
- Prepared, authored, and executed protocols and reports for annual monitoring and shelf-life studies
- Conducted testing to support product release and investigative experiments
- Generated clear and concise LI/NCE/Deviation reports detailing events and their impact on products and processes
- Participated in initiatives to enhance operational efficiency and identify cost-saving opportunities
- Collaborated on execution of studies/projects with strategic impact, aligning with organizational goals
- Supported internal/external audits
- Assisted regulatory teams with product submission and registration processes
R&D Senior Scientist
Hologic, Inc
San Diego
07.2007 - 07.2019
- Led comprehensive studies—including feasibility, assay integration, verification, validation, and stability testing—for CE marking and FDA submissions
- Developed multiple molecular diagnostic products for women’s health and infectious diseases from feasibility to verification and validation
- Led clinical studies as study lead, coordinating efforts to validate new product claims in women’s health
- Designed and conducted mid to high complexity experiments, analyzing data to derive insights and support product development
- Collaborated with cross-functional teams to execute analytical studies, advancing assay development and ensuring alignment with project goals
- Authored and reviewed protocols, validation reports, and technical memoranda, ensuring clarity and compliance with regulatory standards
- Conducted troubleshooting and investigations to resolve technical challenges
- Managed and maintained high-throughput instrumentation (TIGRIS, Panther, Panther Fusion systems) and provided technical support
- Oversaw acquisition and management of large cohorts of clinical specimens
Education
BS - Biochemistry and Cell Biology
University of California, San Diego (UCSD)
Skills
- Design Controls (21 CFR 820, ISO 13485)
- Risk Management (ISO 14971, FMEA, Risk Files)
- Verification & Validation (V&V)
- CAPA, NCEs, Deviations, Root Cause Analysis
- Technical Documentation & Reporting
- FDA, Notified Body & Internal Audits
- Manufacturing Transfer & Product Launch Support
- Test Method Development & Data Analysis
- Statistical Analysis (JMP)
- Design of experiments
- Data analysis
- Product development
- Assay development
- Microsoft Office Suite
Certification
Certified Quality Engineer (CQE), American Society for Quality, 151879008, 06/30/25
Publications
Available upon request
Timeline
Design Quality Engineer III
Hologic, Inc
03.2022 - 01.2026
Staff Scientist
Invivoscribe
12.2020 - 03.2022
Operations Senior Scientist
Hologic, Inc
08.2019 - 12.2020
R&D Senior Scientist
Hologic, Inc
07.2007 - 07.2019
BS - Biochemistry and Cell Biology
University of California, San Diego (UCSD)