Mayank Sharma

Responsible for being the prime quality representative for design control projects at BD (Urology and Critical Care) Site Working with Program Managers and approving design history file documentation in support of design controls, ensuring technical files and Design History Files are auditable Managing: quality planning; verification and validation planning and execution; risk management etc Verification of design specifications, reviews and approves Change Orders and/or product release Authorizations

Responsible for handling and addressing Quality compliance systems and processes related to Quality Management System (QMS), Change Management, Supplier Quality Assurance and collaboration with relevant counterparts. QA representative for implementing Global QMS changes: Change Order’s (QCH), Record change orders (RCH), Deviations (DVN) Complaint Handling process, complaint investigation, documentation and closure Supplier (OEMs) & Distributor Management Process Leading ISO 13485 external supplier audits

Worked with Stryker’s Global Merger & Acquisition Team. Involved in the on-boarding process of the suppliers, supplier audits, Change control agreements & Quality agreements execution, Supplier audit Nonconformance closure Key Player in Merger & Acquisition audits of new Suppliers Conducting Supplier Audits by collaborating with Sourcing, R&D & division QA Leads Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval. Creating Quality Agreements for OEMs/CM

Monitoring & Development of the Quality Management System at Plant level, ensuring ISO compliance, managing the engineering Change Process across the Organization Implementation & Development of documentation for ISO 9001:2015 standard, including Control Plans, Process Control Sheets, SOPs, PFMEA, Flow Diagrams, WIs, Quality Objectives etc. Conducting Internal Audits and Management Review Closure of Nonconformities observed during External audits & Customer audits and CAPA Corrective Actions-8D reports

Participated in Advanced Product Quality Planning (APQP) process to achieve PPAP for designated suppliers Analyzing incoming material defects (mechanical, electrical & plastic parts), disposition and drive corrective or preventive action as necessary Improving overall production efficiency by working together with production and maintenance in developing and modifying process Conducted Gauge R&R for critical Equipment to avoid BIAS in measurement system & ensuring timely calibration of instrument

Achieved 75% in Bachelor of Technology