Daphne Alicia

I’m a Medical Device Quality & Regulatory Affairs professional with 11+ years of experience standardizing and harmonizing Design Control processes, SOPs, forms, and templates across multi-divisional medical device organizations. I focus on translating fragmented, divisionalized practices into unified quality systems that are consistently compliant and ready for audits.

I’ve led full Quality Management System assessments against FDA 21 CFR Part 820 (including Design Controls, 820.30) and ISO 13485, conducting cross-functional gap assessments and driving remediation planning. My work centers on improving documentation integrity and ensuring teams adopt standardized, harmonized processes across global and local business units.

As a Lead Engineer (Team Lead) – System Engineering & Risk Management at HCL Technologies, I led a multi-year manufacturing site transfer change control program, standardizing design control and change management across a 25–30 person global and local cross-functional team. I own Design Controls deliverables—Design Input Requirements, Design Output Review, and Design Verification & Validation—while conducting trace analysis and design reviews to ensure traceability and consistency, including full ISO 13485:2016 and 21 CFR Part 820 readiness.

Earlier, I served as a Regulatory and Quality Specialist and previously worked on DHF remediation and quality engineering, including internal audits, SOP development, and ISO 14971 risk management (PHA, DFMEA, risk evaluation, and risk control). I also bring a stakeholder-first mindset—partnering with R&D, Quality, Regulatory, and Engineering to build practical documentation, CAPA activities, and post-market risk reviews that strengthen overall QMS performance.