Alan Witte
Senior Product Quality Engineer @Convatec
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WORK HISTORY
Senior Product Quality Engineer @Convatec
Led a global quality plan overseeing and successfully closing 20 CAPAs across multiple regions, prioritizing activities based upon risk assessments, regulatory requirements and patient safety impact resulting in a reduction of new nonconformance records and repeat quality findings in audits.Served as the design assurance lead across 4 product development programs, owning risk management from early concept through post-launch change control. Kept design history files current with regulatory changes by working directly with R&D and regulatory affairs at key project milestones, contributing to zero major findings during external audits.Authored and maintained the full suite of ISO14971 risk documents (i.e. Hazard Analysis, dFMEA, pFMEA, uFMEA, and Risk Management Reports) within the Design History File across a product’s complete life-cycle, ensuring traceability from hazard identification through residual risk acceptance for new product development as well as EU MDR remediation.Guided R&D teams through the translation of user needs into verifiable design inputs, then confirmed that design outputs and verification testing closed the loop on each requirement - catching gaps before they reached V&V or regulatory submission.Owned risk management documentation and DHF for a powered negative pressure wound therapy device requiring IEC 60601 electrical safety compliance and SaMD considerations with awareness of IEC 62304 software lifecycle documentation, collaborating with engineering teams and external test houses to ensure safety and essential performance requirements were fully traced through the risk file.Represented design assurance during Notified Body external audits with zero findings attributed to design control gaps. Prepared audit-facing documentation and coached cross-functional team members on responding to auditor inquiries in real time.
EDUCATION
The Ohio State University
Bachelor of Science (BS), Biomedical Engineering
ABOUT ALAN WITTE
A Senior Design Assurance Engineer with 10+ years in medical device quality, specializing in risk management, design controls, and CAPA leadership across Class devices. Experienced in EU MDR remediation, powered device compliance and cross-functional quality ownership within ISO 13485 QMS environments.
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