Bhavin P.

About Bhavin P.

Strong Compliance and Technical Quality Expert with a deep understanding of New Product Development fundamentals, Quality Management System, CAPA and Supplier Quality Management with over 18 years\' experience in the Medical Device and Pharmaceutical sectors. Possess in depth understanding of the full product lifecycle ownership from conceptualization through sustaining and end of product life. Throughout my career, I have consistently upheld the highest standards for process improvements and operational efficiency. As an expert in Quality System, I have consistently delivered on the mission of enhancing product quality, regulatory compliance and risk management to maximize its operational efficiency. Exceptional team leader with strong data-driven decision-making skills with strong track record of maintaining high-quality standards in the supply chain through supplier audits and inspections. A proven leader in fostering a culture of excellence and continuous improvement.As a certified Medical Device Auditor and IPC Trainer, I have extensive expertise in quality management systems, supplier qualification, internal and external audits, design validation and verification, and process validation. I have successfully led and supported multiple product development and manufacturing process improvement projects for Class I, II, and medical devices, including active implantable devices.

Experience

1. Corporate Qa Manager - Supplier Quality

   PTC Therapeutics, Inc.

   Jun 2021 — Present

Education

• Sardar Patel University

  Eletronics Enginering

• Sardar Patel University

  Masters, Electronics

  2002 — 2004