Aalok Marathe

Background

About Aalok Marathe

I’m a Quality Assurance professional with over 5 years of experience supporting regulated manufacturing environments across the medical device, diagnostics, and pharmaceutical industries. My career has centered around maintaining high-quality standards through CAPA management, non-conformance investigations, risk assessments, and validation support — always with a focus on compliance, collaboration, and continuous improvement. In my current role as a Quality Engineer at Mason Technology, I work within ISO 17025 and ISO 9001 frameworks, contributing to audit readiness, documentation control, and system compliance across multiple laboratories. I’ve developed strong capabilities in change control, quality documentation review, deviation handling, and cross-functional collaboration with QA, Engineering, and Compliance teams. Previously, I worked at West Pharmaceuticals, a global medical device manufacturing company, where I operated within ISO 13485, FDA 21 CFR 820, and EU GMP frameworks. I supported sterile manufacturing operations, performed in-process quality checks, and contributed to process validation and equipment qualification activities. I was actively involved in internal audits, developed and revised SOPs and validation documentation, and led root cause investigations tied to both human and equipment-related deviations. This hands-on manufacturing QA experience gave me a deep understanding of product lifecycle quality control and the regulatory standards governing combination products and parenteral packaging components. I’m actively seeking opportunities where I can contribute as a: Supplier Quality Engineer Quality Assurance Specialist / Analyst QA Operations Officer / Technologist Manufacturing Specialist I bring a proactive mindset, attention to detail, and a systems-based approach to solving quality challenges — whether it’s ensuring compliance, improving documentation processes, or supporting manufacturing quality on the floor. Let’s connect if you're looking for someone who can drive quality excellence from the inside out.