Manjul Pratyush

 Technical Leadership: Leading a team of 11 senior/lead quality engineers to support global VAD sustaining projects and NPD quality activities and site leader for the CAPA activities.  Cross-Cultural Collaboration: Supporting 50+ CCPs as a team to support Reynosa plant by collaborating with Reynosa manufacturing site and SLC design center engineer, global suppliers and BDTCI and TCS team members.

 Quality Leadership: Led NPD Quality engineering function for 1 of the 3 sub-system for complex global engineering program co-developed at US, Italy, China and India.  Cross-functional Collaboration: Worked with Marketing, R&D, Packaging, Quality, Regulatory, Operations, Manufacturing, Project Management, Internal and External labs, Labeling and Technical communication for establishing relationship and effective communication.

 Project Management and Ownership: Led the Quality Assurance for NPD program by Quality planning and ownership of Design control activities including Design verification and validation, Risk management, DHF contents and managing Design reviews and contribution in other areas.  Problem Solving: Travelled US (R&D Headquarter) and Ireland (Manufacturing center) couple of times to solve design/process challenges, stakeholder management, idea exchanges and global discussions building strong global relationship

 Leading by example: Set the design quality function roles, responsibility, and standard by successfully establishing RMS-PM Design Quality function at the MEIC Hyderabad.  QMS Support: Established multiple QMS procedure by leading cross-functional team adhering to ISO13485 expectations and corporate guidance.  Audit Management: Certified experience Lead auditor from BSI Academy from 2014. Managed Internal and supplier audits for 2 years, worked as lead auditor for 10+ internal audits

 Team Building: Establish the Design Quality Function for new client by building a team of 5 QEs from scratch by continuous training, guidance and mentoring to team members.  Conflict Management: Supported 8+ global projects involving 30+ FTEs by providing clear quality expectations and continuous and proactive communication.