OSEI, JOHNSON, PMP Cell: 434-***-****

*** ********* *****

Charlottesville, Virginia 22923 Email: adwnaa@r.postjobfree.com:adwnaa@r.postjobfree.com

Objective

Obtain a leadership position that will fulfill my desire to use my engineering education and working experience to maintain and improve quality associated with systems, processes, and products for a medical device company.

In depth experience in Product Development, Research /Development, Project Management, Manufacturing/Operations, Process Development, Testing, Quality Assurance/Engineering, and Regulatory Affairs of medical devices.

Experience

MICROAIRE SURGICAL INSTRUMENTS, Charlottesville, VA. Jan 2016 - Present

Quality Assurance Engineering Manager, PMP

Leader of quality professionals including Quality Systems, Quality Engineering, Quality Control, Supplier Quality and Process Control & Monitoring. The QA department comprising of ~28 personnel.

Responsible for Quality Engineering in Management Review to ensure key quality metrics and objectives are met. This includes improvements to key quality systems, e.g. Complaints, CAPA, Validations, Risk Management, etc.

Responsible for all QA management and oversight for MicroAire including Operations, Infrastructure and New Product Development (R&D). This includes compliance with US (FDA) and International (EU, TGA, Canada, Brazil, S. Korea, etc.) regulations

Responsible to set quality objectives for MicroAire Surgical Instruments to drive improvement, e.g. CAPA reduction, material and process non-conformance reduction, complaint rate and analysis.

Responsible to ensure key New Product Development, Quality System and Continuous Improvement projects meet regulatory and quality requirements.

Responsible to drive improvement Quality to improve key quality metrics.

Ensures audits and inspections conducted by state and federal regulatory agencies and accreditation/certification bodies, which includes FDA, ISO, Customer Audits, and International Regulatory bodies

Sr. Quality Engineer

●Develop new/improved products/processes and techniques for engineering tasks.

●Develop risk management plans, reports and utilize risk management tools such HAs, FMEAs, FTAs

●Develop, review, and approve Engineering Change Orders, Protocols and Reports.

●Provide direction in developing inspection plans, First Article Inspections, in-process, and Final Product Inspection.

●Coordinate and participate in elements of investigations regarding customer complaints.

●Apply sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

●Support the validation of product designs, manufacturing processes, equipment, and procedures required to the production and delivery of finished products.

●Support the execution of design control.

●Initiate and direct corrective actions to problems relating to product or process quality.

●Supplier Quality Audits and Corrective Action Activities (CAPAs).

●Internal and External Audits and Support.

●In dept knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines

●Development of a Standard Procedure (SOPs), related Work Instructions (WI), Forms, Checklists for design verification and validation activities

●Excellent knowledge and experience in CAPA.

●Creation of Quality Plans and Execution of Quality Plan Deliverables.

BAXTER HEALTHCARE CORPORATION, Deerfield, IL Nov 2009 - Dec 2015

Senior Principal Engineer (Quality)

●Analyzed data from various sources (including, but not limited to: Non-Conformances, FCA, MDR, Complaints, etc.) to drive decision-making and effective corrective/preventive actions.

●Provided quality engineering guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.

●Developed, reviewed, and approved engineering change orders (ECOs')

●Planned and led analyses, tests, verifications, inspections, and integration of design to ensure the quality of components and/or products.

●Worked in project teams to identify compliance risks during the product development cycle.

●Identified and worked on significant issues or developments identified during quality assurance activities and provided recommended improvements.

●Prepared and presented technical and PDP program information to team members and management.

●Educated, trained, and facilitated project teams on design control best practices by partnering with various functional departments.

●Utilized Design for Six Sigma (DFSS) tools to promote a disciplined approach to product and process designs to ensure product quality and process capabilities.

●Worked fully in corrective and preventive actions (CAPA)-related activities, including CAPA ownership.

●Identified, recommended, and led various projects for improvements to the quality system.

●Authored, reviewed, and approved work for inclusion in Medical Device Reports (MDR’s) and provided leadership in the management of investigations supporting MDRs

HOSPIRA, Inc., Lake Forest, IL Oct 2005 - Nov 2009

Senior Development Engineer

●Developed products for IV Therapy (Disposables/Consumables).

●Implemented Design Controls and Quality Systems of assigned projects.

●Reviewed and analyzed complaints on products, determined root cause(s) and implemented corrective actions.

●Wrote/reviewed protocols/reports, performed Qualification/Validations and Design Reviews.

●Performed engineering functions for product and process improvements.

●Wrote/authored documents for product and process specifications and procedural changes.

●Broad knowledge of applicable regulations and standards (QSR, ISO 13485) and how to apply the principles, practices, and procedures.

RMLS, Inc., Des Plaines, IL Nov 2003 - Oct 2005

Business Owner

●Started financial consulting company in the states of Illinois and Georgia

●Ran day-to-day operations in Illinois and oversaw operations in Georgia

●Oversaw all lending activities in both states.

●Managed and supervised brokers and loan officers.

●Performed sales and marketing for the company

BAXTER HEALTHCARE CORPORATION, Deerfield, IL Oct 2001 - Nov 2002

Senior Principal Engineer

●Managed Quality Engineering and Manufacturing/Operations and supported Global Plasma Sourcing operations and Quality and Regulatory bodies in North America and Europe.

●Established quality standards and procedures for facility construction, equipment calibration/maintenance and manufacturing/operations.

●Performed mechanical equipment and process validations. Performed tracking and trending of key quality indicators.

●Managed and supervised engineers, technicians, and operators.

●Provided leadership for assigned CAPA activities; oversaw equipment calibration and maintenance functions.

●Authored, reviewed, and approved quality related protocols, studies, and reports.

ALLEGIANCE HEALTHCARE (Cardinal Health), McGaw Park, IL Feb 2000 - Oct 2001

Senior Principal Engineer, Research & Development

●Developed new products for Preoperative Surgical applications and development/packaging of pharmaceutical and medical products.

●Tested products for reliability. Processes and materials’ validations/qualifications for production.

●Managed contract manufacturing, product/process improvements and cost reductions (VIP).

●Designed delivery systems for OTC/NOTC drugs.

●Worked on Blow/Fill, Aseptic filling and liquids filling/capping machinery development and implementation.

●Obtained patent #6,533,484, Small Applicator for Antimicrobial Solution.

SABRATEK CORPORATION, Skokie, IL Nov 1998 - Feb 2000

Senior Engineer, Manager Disposables Manufacturing; Manager, Regulatory Affairs

●Developed prototypes and new products for IV Therapy (Disposables).

●Worked on Design Controls, ISO/Quality Systems and CE Mark filing and implementation.

●Researched costs and made Capital Equipment purchases.

●Performed Qualification/Validations and Design Reviews.

●Performed all engineering functions from concept phase to pilot production and scale up.

●Designed and launched new products.

●Performed sustained engineering and provided supporting documentation.

●Managed Disposables in-house manufacturing and contract manufacturing in the US, Mexico, and Spain.

●Developed and Implemented process improvements, planned, and scheduled contract manufacturing.

●Led FDA and ISO Audits. Performed Registrations and Complaint analyses with corrective actions and customer responses. Also led Internal and External Quality Audits.

CRYOCATH TECHNOLOGIES INC., Montreal, CANADA Feb.1998 - Nov.1998

Manager, Manufacturing Development/Operations

●Completed feasibility study for manufacturing and pilot production.

●Initiated facility and executed start-up manufacturing facility for a cryoablation catheter production.

●Managed work cell manufacturing and control systems to increase flexibility and facilitate shop floor control.

●Worked with R&D on cryoablation catheter design and manufacturability.

●Developed documentation for pilot to scale-up production.

●Directed and promoted production capacity, quick response to clinical trials and customer demands.

●Managed projects and maintained production efficiencies through prototyping and debugging for optimization.

●Supervised 2 engineers, 3 technicians and various operators.

CORDIS, (a Johnson & Johnson Company), Miami, FL Jan 1991 – Jan 1998

Senior Engineer Product Development, Senior Process Engineer (1995 –1998)

●Developed new products and transferred to production for commercialization.

●Worked with physicians in the US and Europe to develop new products.

●Developed and implemented new and improved processes.

●Developed tool control system and updated tools and equipment.

●Investigated field complaints and implemented corrective actions.

●Worked with sales representatives (product managers) and doctors to develop products that became standard product lines.

●Developed knowledge of products, processes, clinical uses, documentation, and tooling to educate medical personnel.

●Wrote procedures and performed test methods validations.

●Managed and led Special (R &D)/Pilot Projects as Project Leader.

●Developed and implemented manufacturing documentation.

●Provided engineering support for production lines with tooling and fixture designs.

Quality Assurance Engineer, Senior Quality Assurance Engineer (1992 - 1995)

●Generated validation and qualification protocols and technical reports for new products and processes.

●Investigated and implemented corrective actions for on-line process defects and field complaints. Wrote standard operating procedures (SOP’s) and specifications.

●Performed design reviews. Performed reliability analyses to address clinical issues of products.

●Validated processes, qualified new products, and suppliers/vendors.

●Worked with Research and Development groups from conception phase of new products to production phase.

●Developed and implemented Quality Systems. Performed internal quality audits.

●Generated FMEAs for new products and processes.

●Developed and launched new products and line extensions of existing product lines.

Quality Assurance Technologist ASQ Certified (1991 - 1992)

●Assisted engineers in testing, analyzing, and qualifying new products.

●Generated new process and equipment protocols and implemented new processes and products.

●Provided statistical analysis of processes and products' data. Performed process validations and product qualifications.

●Trained engineers and technicians in statistical methods and applications.

●Led laboratory test reviews. Tested and qualified line extensions for existing products and participated in qualifying suppliers

FLORIDA INTERNATIONAL UNIVERSITY, Miami, FL 1991

Graduate Teaching Assistant

●Assisted teaching undergraduate students in Automation and Robotic Assembly Cell.

MIAMI DADE COMMUNITY COLLEGE, Miami, FL 1991 - 1992

Instructor

●Taught Intermediate Algebra

TASK ENGINEERS & LABORATORIES INC., Miami, FL 1988 - 1991

Laboratory Technician, Assistant Engineer

●Evaluated and qualified pavement structures and concrete designs.

●Played key role in material evaluations, testing and analyses of airport paving structures.

●Developed testing methodologies for airport designs.

●Developed and implemented the first quality system in the company.

EDUCATION

M.S. Industrial Engineering (completed up to Thesis Level)

Florida International University, Miami, FL

B.S. Mechanical Engineering 1988

Institute of Technology, University of Havana, Havana, Cuba

ORGANIZATIONS/ASSOCIATIONS

●ASQ-American Society of Quality - Certified

●Project Management Institute (PMI) - Certified

●Institute of Industrial Engineers - Member

●Society of Manufacturing Engineers - Member

●United Nations Association - Member

Contact this candidate