Tanveer Wahid, MBA, M.E.

Experience

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  IPFW

  Aug 2002 - Jul 2004

  Independent Business Consultant

  • • Developed and Maintained a Marketing Database for Continuing Studies Marketing Department Project• Designed an automated Executive Report of student enrollment for the Director of Continuing Studies using oracle based Brio-query and wizard based ES Designer software• Led the phase I design project to develop a campus-wide contact database for university engagement activities with outside community for the IPFW Development Department

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  Ottenweller Company

  Aug 2004 - Jul 2005

  Operations Facilitator

  • • Reporting to Operations Manager, Led continuous improvement projects, lean manufacturing projects and 5S programs to increase operations efficiency• Provided counseling and training on best practices and error-proofing techniques (including RCA, SPC)• Managed APQP projects, including PPAP compliance, PFMEA, process capability studies• Active member of Six Sigma and Lean Projects to decrease quality rejections and improve efficiencies

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  Ottenweller Company, Inc.

  Aug 2005 - Feb 2008

  Quality Assurance Manager

  • • Reporting directly to President, responsible for the quality management and regulatory compliance of 2 US manufacturing facilities generating $40 million revenue• Liaised with external Customer with issues and projects related to Quality System• Developed quality specifications (Q-specs) and Responsible for ISO 9001:2000 Certification project• Member of Management Project Team reporting Quality Management System effectiveness• Analyzed and Communicated quality performance at all organizational level as defined by the customers • Initiated environmental compliance program for ISO 14001 certification• Supervised a group of 15 Inspectors, Auditors and Quality Technicians and Engineer Show less

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  Dynex Technologies

  Mar 2008 - Dec 2015

  • Manage and develop quality specifications and management system that complies with ISO, cGMP, FDA, IVD and other healthcare regulations• Interpret and communicate Quality System requirements at all level of the organization including supply chain• Responsible for compliance and assist in preparation of 510k filing, technical files for EU and International regulatory bodies• Coordinate inquiries and act as Management Representative for inspections and audits from customers, FDA and other regulatory bodies• Work with distributors and consultants in registering products in China, Brazil, Mexico, Malaysia, Saudi Arabia, Russia and other new and emerging markets.• Provide input for Quality and Regulatory Affairs in new product development and existing product enhancement projects• Responsible for execution of CAPA, Audit, Risk Management and other Quality Critical programs• Oversee the Health & Safety Program as the Safety Officer of the company Show less • Actively Contributed with the development of written processes, procedures and work instructions• Implement risk management through Audit, CAPA, NCR, RCA, PFMEA, process capability studies• Audited and Evaluated critical and potential suppliers and Coordinated with them in resolving open action items for supplier approval process.• Analyzed customer and supplier issues and then Executed pro & reactive improvements• Responsible for mentoring, development and effectiveness of Quality Engineering, Document Control, QC Inspector and Auditors• Represented Quality Assurance and Quality Control in MRB meeting & manufacturing floor Show less

  • Quality Assurance Manager

    Mar 2011 - Dec 2015

  • Quality Engineer / Site Quality Lead

    Mar 2008 - Feb 2011
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  Brainscope Company Inc.

  Jan 2016 - Nov 2017

  Quality Manager

  • Reporting directly to CEO, responsible for leading quality efforts for Design Control, Software Quality, V&V, Reliability Engineering, Manufacturing Quality and Post Market Quality Functions • Created Strategic Quality Vision, New Departments that included V&V, Reliability Engineering, and Software Quality to enhance business/compliance goals• Authored multiple Quality Policies to enhance Quality Systems. These include Change Control in Development, Reliability Testing, and Configuration Management thru product life cycle, Risk Management for ISO 14971• Led, Managed and Navigated projects for successful ISO 13485, TUV and FDA Mock Audits. No Major findings• Managed and Led Quality related Continuous Improvement (CI) projects (Product Quality Enhancements, Process and System Improvements, Compliance Readiness) using Process (DMAIC) and Design Six Sigma methodologies• Led the Class II readiness project for enhancing the Regulatory Compliance to meet Design, Production and Post-production requirements in a cGMP environment• Led and Established critical characteristics identification and supplier outgoing inspections programs to improve product quality and reduce cost of quality• Established Supplier Management Programs and Partnerships to improve Product Quality, reduce Inspection Costs and support Cost of Quality improvements• Coach, Manage and Develop direct reports for next level role or expansion in current role by setting clear expectations, providing frequent feedback, and supporting development plan efforts• Collaborated to create Organizational Training Strategy for QMS to deliver an effective training program that consists of multiple learning methodologies, structured training program and role based training• Successfully Led multiple Corporate CAPA projects to enhance QS tools and assure compliance to FDA and other regulations• Partnered with external consultants and vendors in projects to deliver various aspects of corporate initiatives Show less

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  Philips

  Dec 2017 - now

  Quality Leader

  • Spearheaded Quality & Regulatory for development and manufacturing of class II medical software and hardware system using AI and deep learning for neuro diagnostics.• Analyzed and then effectively strategized about business goals, deadlines, schedules, budgets, needed resources and team member coordination.• Managed Quality System Transformation Project in two 6-week sprints that involved over 3,100 consulting hours (~$500k Budget), on time and under budget at Philips Neuro.• Led a team of 5 engineers in requirement gathering to understand the market need and feasibility.• Prepared project documentation, deliverables, finances, resource allocations, and status for all Quality Integration and Remediation Projects.• Responsible for budgeting, forecasting, expense and status reporting, risk management, and execution.• Collaborate with participants to determine project timelines.• Created and managed master program plan for new and implemented quality processes and tools required to ensure product quality and customer satisfaction.• Formulated and implemented the Business’ long-range quality, regulatory and compliance policy with responsibility for managing $1.06mil budget.• Enforced (a simplified) quality systems and harmonized them across the Business sites and Sector; established an effective Management Review process, including routine reporting.• Manages product recall activities to include recall policies and procedures for the company. Additionally, manages product compliant activities and processes.• Directs the internal and external Audit Program for the organization.• Drafts and manages the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan). Show less