Dolapo A Babalola

About Dolapo A Babalola

I am an experienced Quality Engineer with 5+ years experience in Quality Assurance, Design Assurance, Continuous Improvement, Mechanical Engineering and Data Analytics functions. I have a Master\'s degree in Industrial Engineering/Management with a Graduate Certificate in Lean Six Sigma and a Bachelor\'s degree in Mechanical Engineering. A skilled Quality Engineer who is a critical thinker with a professional and intellectual demeaner. Also, an excellent performer who pays great attention to detail and who is able to meet and exceed expectations. I have exceptional abilities working as an independent contributor or collaborating with cross functional teams. I have experience working with US companies operating within Biopharma/Biotechnology/Bioprocessing and Medical device industry. My skills and competencies includes Quality Assurance, Root cause Analysis, Investigations, Product Quality, Design Assurance, Design Verification, Design Validation, Continuous Improvement, Process Improvement, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), ISO 9001:2015,Knowledge of 1SO 13485, Project Management, Corrective and Preventive Action (CAPA), Quality Control, Deviations, Internal and External Audit, Document control, Change Control, Risk Assessment/FMEA, Data Analytics, Data Visualization, Predictive Analytics, Data collection and Management, Lean & Six Sigma Methodology. Lastly, I have experience using the following tools & technologies some of which includes Trackwise, Veeva QMS System, Oracle, Minitab, IBM SPSS, Tableau, PowerBi, Microsoft Excel, Smart Sheet, Jira, Miro, PostgreSQL, SQL Server, SalesForce, AutoCAD, Microsoft Excel, Microsoft Powerpoint, Microsoft Word and Microsoft Office

Experience

1. Lead Engineer -quality Continuous Improvement

   Cytiva

   Jan 2022 — Present

   Collaborate with R&D and SQE to assure that no negative impact are made to raw material and finished goods products during design changes. Provided technical inputs and reviews for design verification/validation, risk management, tech assessments, sampling size strategy for over 60 design change projects. Provide technical inputs to ensure that QMS requirements, user requirements, functional and performance requirements are met during NPI design and development. Participate in risk identification to assess product quality impact and provide adequate short and long-term risk mitigation actions to eliminate or lower risks. Lead quality events or assigned as quality approval to investigations resulting from product/process non-conformances related to methods, processes, and product design issues. Resolved and supported over 50 quality events and CAPA actions affecting Quality control processes, mfg, WH processes etc. Quality participant in the deviation and concession process responsible for creating deviation and concession records or supporting cross-functional teams. Evaluate quality issues, provide recommendation on pre and post-implementation actions for deviations based on risk level, and review records for accuracy and adequacy in compliance with GDP and data integrity policies. Lead QA continuous improvement program across two sites by ensuring that continuous improvement requests that foster QMS improvements, process dev, standardized processes are completed using appropriate problem-solving tools, and deliverables are well-defined. Facilitate biweekly meetings with over 10 QA Engineers to track project updates. Responsible for development of key metrics and Metric Dashboards for Quality operations to understand process performance and improvement opportunities. Develop and update QMS documentations to ensure effective operation of the QMS and compliance. Support Audit program as an Internal Auditor for key processes and provide external audits support.

Education

• University of Central Missouri

  Master's degree, Engineering/Industrial Management, 4.0/4.0

  2017 — 2019

• Ladoke akintola University of technology, ogbomoso, oyo state.

  B. Tech, Mechanical Engineering, 3.98/5.0

  2009 — 2014