pratik kale
Complaint Investigator@ Philips
Pune, Maharashtra, India
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Pratik Kale is an engineering professional with 11.2 years of experience. He has expertise in process validation, lean manufacturing, research and development, and quality assurance. Pratik has worked in various roles, including Complaint Investigator at Philips and Quality Engineer at Zimmer Biomet. He is skilled in Microsoft Office, Excel, and PowerPoint, as well as leadership, research, and document control. Pratik is based in Pune, Maharashtra, India. He is actively involved in all stages of process validation and verification, with a strong background in FDA regulations.
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Emails and Phone Numbers

@philips.com
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About

Engineering professional with in depth work experience in process validation, lean manufacturing, research and development, and quality assurance, Quality System programs including CAPA, Audits, Supplier Quality, Risk Management, Complaint Investigations and Document Control. Experience in Root Cause Analysis, Corrective and Preventive Action, process verification/validation, Assembly line, Current/new Product, Process Development, Test Method Validation (TMV) quality improvement and cost reduction for manufacturing facility of various products to ensure high level of process and product quality. Actively involved in all the stages of process validation – Process Design, Process Qualification, and Process verification. Excellent knowledge of quality systems and FDA regulations including a strong background in FDA 21 CFR Part 820 compliance and ISO 13485, 14971, 15223 & 15378.

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Work Experience

Amstelplein 2, Amsterdam, Noord-Holland, 1096 BC, NL

Hospitals and Health Care

71288
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pratik kale's Professional Milestones

  • Quality Engineer (2017-02-01~): Developed and implemented comprehensive quality control measures, ensuring the product meets customer specifications and ensuring customer satisfaction.
  • Product Design Engineer (2012-07-01~2014-07-01): Developed innovative designs that captivated audiences, resulting in increased product quality and customer satisfaction.
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