プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Rajesh K.に依頼

Netherlands

Quality & Regulatory for MedTech Professional with 25+ years of working experience in International Regulatory Landscape

プロフィール概要

Take up projects in all areas of Quality and Regulatory of MedTech, Automotive and High Tech

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971

サービス

• Consulting

Consulting Regulatory Consulting, Manufacturing Consulting

職務経験

Owner / Consultant

KMS Solutions B.V.

8月 2023 - 現在

Head of Quality

Philips Healthcare

1月 2011 - 7月 2023

Sr. Auditor/Quality Leader

GE Healthcare

7月 2000 - 12月 2010

Supplier Quality Assurance Executive

Delphi Automotive Systems (GM)

6月 1996 - 6月 2000

Supplier Development / Quality

JBM (JV of Suzuki Motors India)

1月 1992 - 5月 1996

学歴

PGP in Management

International Management Institute Delhi, India

6月 1994 - 5月 1997

Bachelors og Engineering - Mechanical

National Institute of Technology Surat - India

8月 1987 - 7月 1991

認定資格

• Certified Lead Auditor ISO13485/9001

  IRCA

  1月 2008 - 現在