Senior QS Validation Engineer · Advanced Bionics, part of Sonova
Focused on computerized systems validation, digital quality systems, and risk-based software assurance for medical-device and life-sciences environments.
People. Process. Technology.
Quality connects them all.
01 / A little about me
Senior QS Validation Engineer
Part of Sonova · Medical devices
I work at the intersection of Quality, IT, and business operations. My focus is making validation useful: understanding how systems are used, what could go wrong, and which evidence supports a confident decision.
My experience includes enterprise applications such as SAP, Salesforce, Propel, and RegDesk. I help connect system requirements, risk assessments, testing, and change controls across the software lifecycle.
I’m especially interested in the shift from document-heavy validation to thoughtful, risk-based software assurance, without losing the traceability and discipline that regulated environments need.
02 / What I bring
A connected view of systems, risk, and the people who depend on them. These are the areas I work in.
Computerized systems validation and risk-based assurance, grounded in intended use and meaningful evidence.
User requirements, validation planning, risk assessment, test design, execution evidence, traceability, and validation reporting.
Validation work across business applications that support quality, product, and regulatory processes.
SAP, Salesforce, Propel PLM, RegDesk, and electronic quality-management workflows, with attention to how each system is used.
Connecting system changes to the right reviews, testing, approvals, and post-release checks.
Change-impact assessment, coordination between Quality and IT, review of validation evidence, and verification after production deployment.
Focusing assurance effort on the functions and records that matter most to quality and reliable decisions.
Risk-based prioritization, electronic-record controls, traceable evidence, and validation considerations related to 21 CFR Part 11 and ISO 13485.
Turning lessons from quality issues into clearer procedures, practical controls, and better verification.
Corrective and preventive action support, procedure and template updates, review criteria, and post-release verification checklists.
Bringing Quality, IT, project teams, and system owners together around clear responsibilities and decisions.
Translating technical and quality requirements, coordinating document reviews, clarifying release expectations, and communicating risks and next steps.
03 / Selected work
A few areas of my work, described at a high level to respect the confidentiality of the teams and systems involved.
Showing all 3 projects.
Validation contributions across SAP, Salesforce, and Propel, linking business requirements to testing and controlled change.
Support requirements definition, risk assessment, validation planning, test evidence review, and cross-functional coordination for enterprise application changes.
Keep the connection between intended use, system behavior, and acceptance evidence visible throughout the lifecycle.
Validation support for regulatory information systems, with attention to user needs, functional expectations, and supporting evidence.
Contribute to validation activities for RegDesk, working with project stakeholders to connect requirements, verification activities, and documentation.
Help teams establish and document whether the application supports its intended regulatory information workflows.
Work on clearer release-review criteria, procedure updates, and post-release verification for quality-system changes.
Help develop practical review steps and verification checklists, and coordinate procedure and template updates with Quality and IT stakeholders.
Make responsibilities, evidence expectations, and post-deployment checks clearer for the people handling a release.
These summaries describe areas of contribution, not sole ownership of team outcomes. Internal documents, system records, and confidential project details are not published here.
04 / What I’m building
I’m developing a Digital Validation System concept to bring requirements, risk assessments, testing, and traceability into one connected workflow. The aim is less fragmented documentation and clearer decisions.
An exploratory project, not a production-ready or validated product. The interactive panel illustrates the intended workflow; it does not process real validation records.
From intent to evidence
Describe the system, the people using it, and the quality-relevant functions it needs to support. Connect each requirement to a clear purpose.
05 / Credentials & learning
Professional certifications that complement hands-on validation experience and a continued interest in better quality practices.
Software quality principles, verification and validation, process discipline, and quality-focused engineering.
Earned October 2024 · ASQ CSQE
Quality management, organizational excellence, leadership, and practical process improvement.
Earned September 2026 · ASQ CMQ/OE
Good validation should help people understand a system, make a sound decision, and explain the evidence behind it.
Profile & contact
Interested in digital quality, software assurance, or the next chapter of validation? Download or print this public professional summary for easy reference.
No verified public email or social-profile link was supplied, so none is published here.