Headline

Quality & Regulatory Compliance | Senior Technical Writer | Medical Device Service Documentation | ISO 13485 | FMEA | IQ/OQ/PQ | JNJ MedTech | ISO 14971 | SOLIDWORKS | CAPA✅

About

I am a Senior Technical Writer and Service Documentation Engineer with 3+ years of specialized experience in the medical device industry, currently working with HCL Technologies on Johnson & Johnson MedTech projects. My work focuses on creating high-quality service documentation for complex cardiac electrophysiology devices — including cardiac arrhythmia treatment systems and dual-mode RF/PFA ablation generators. I have built end-to-end service documentation ecosystems from scratch, covering: Depot and Field Service Manuals Installation Manuals and Field Replacement Instructions Service Parts (SP) documentation with BOM, labelling, packaging design, and packaging instructions Service FMEA (Failure Mode and Effects Analysis) Validation documentation: IQ, OQ, and PQ Depot tools lists and depot setup support I recently led a full 6-month documentation project for a Docking Station communicative device — owning the project from planning through depot technician training, including an on-site engagement in Israel. Beyond documentation, I serve as Project Quality Analyst across my projects, ensuring all deliverables comply with ISO 13485 medical quality standards. I also designed a process improvement tool that delivered approximately $15,000 USD in cost savings — drawing on Six Sigma principles. Tools & Tech: MS Word | MS Visio | SOLIDWORKS (Certified) | Adobe Illustrator | Windchill | Agile PLM I am open to opportunities in Technical Writing, Service Documentation Engineering, Quality Engineering, and Regulatory/Compliance roles across medical devices, aerospace, and industrial sectors. Let's connect if you're working on documentation or quality challenges in engineering-heavy domains. Currently upskilling: CAPA certified (Udemy) | ISO 14971 in progress

Location

Chennai

Work experience

Manufacturing / Service Engineer – Medical Devices at HCLTech, Aug 2022 - Present · 3 yrs 11 mos, Shollinganallur, Support regulatory-compliant manufacturing and post-market servicing activities in ISO 13485 and GMP-aligned environments. Coordinate CMC-related technical documentation for labeling, packaging, servicing, and site readiness initiatives in partnership with QA and Regulatory teams. Author Service FMEAs and validation protocols/reports (IQ/OQ/PQ) used to demonstrate process capability during audits and depot launches. Create and maintain multi-level BOM structures in Agile and Windchill; support ECO-driven changes impacting service kits, tooling, and released device configurations. Govern controlled documents and PLM records to ensure alignment with approved regulatory configurations and manufacturing releases. Compile evidence packages supporting audit readiness and regulatory inspections, including validation records, service documentation, and training matrices. Lead onsite dry runs and GMP documentation training for international depots and field teams. Coordinate cross-functional teams across Manufacturing, QA, Packaging, and Engineering to meet regulatory timelines for site activation and service readiness.

Virtual Internship programme at Roots Industries India Limited, Nov 2020 - Dec 2020 · 2 mos, Coimbatore, Tamil Nadu, India

Education

MBA In Distance Education, System management, University of Madras

Bachelor of Engineering - BE, Mechanical Engineering, Government College of Technology, Coimbatore