Servesh Kumar Email & Phone Number

Senior Engineer (Regulatory Affairs) with expertise in EU-MDR & US-FDA submissions, DHF preparation, and quality standard development. Proficient in FDA regulations and ISO 13485, experienced in gap assessments, risk management, and product specification document approval. Skilled in liaising with different teams to ensure compliance, the effectiveness of CAPA, and product labeling/packaging conformance.Also experienced in Project Coordination, ensuring adherence to frameworks, and maintaining project plans and schedules while keeping costs under control. Hands-on experience in conducting design development review meetings, establishing quality management systems, and utilizing quality tools.As an NPD Quality Control Engineer, experienced in problem-solving, waste reduction using Six Sigma and Lean Manufacturing, and quality management system establishment aligned with the production department. Skilled in VOC representation, COPQ identification, CAPA implementation Statistical Data Analysis, MSA (Gauge R&R), FMEA, and 8D tools use. Proficient in ISO 9001:2015(QMS), ISO 14001(EMS), and ISO 45001(OH&S) audit leadership, and statistical data analysis for variable/Attribute data using Minitab.

Listed skills include Microsoft Office, Manufacturing, Management, Leadership, and 19 others.

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  National Institute Of Technology Hamirpur

  Mechanical Engineering