Manager Project

Gregory Damien Rosa

Phone: 949-***-****

PO Box 1472 Mammoth Lakes, CA 93546 Email: ***************@***.***

Executive Profile

Manage multiple medical device manufacturing projects in various locations with a strong focus on product development and lean manufacturing. Projects include design control with effective tracking of the design process through stage gates, design reviews, validation and verification activities. Over five years experience managing projects in medical device products and manufacturing process development with design control experience. Developed product best practices in a matrix organization where strategic thinking and problem solving capabilities are essential while influencing the team as a whole. Initiating, planning and executing all aspects of projects to ensure a successful closure. Innovative and results driven leader focused on achieving exceptional results in highly competitive environments that demand continuous improvement through automation.

Education

Masters in Business Administration (MBA) 2011

Argosy University, Los Angeles/CA

Masters of Science Engineering Management (MSEM) / Six-Sigma Black Belt 2005

Total Quality Management Certification (TQM) / Six-Sigma Green Belt 2003

University of South Florida, Tampa/FL

Bachelor of Science in Mechanical Engineering (BSME) 2002

University of South Florida, Tampa/FL

Core Competencies

Project Management of Multiple simultaneous Projects in the Medical device field.

AS9100 and ISO9001 implementation and registration.

Use corrective actions to adjust projects as they progress ensuring risk mitigation.

Developing and track continual improvement as processes are implemented.

Creating Research and Development Action Plans for new products.

Coordinated projects with various international manufacturers with success.

Natural leader who can mentor others and help them reach their full potential.

Expert at building relationships and procuring new equipment / human resources to assist with project implementation and machine design.

Highly knowledgeable in the best practices used in effective project management.

Professional Experience

Rosa Consulting, Laguna Hills/CA

Project Manager (Medical Device Industry/Quality Systems Specialist)

2009 - Current

Consulting work with Johnson & Johnson and Jewel Medical (Medical Devices)

Quality Management System development using Lean Manufacturing, Six-Sigma and Obeya concepts.

Manage Projects in business development and quality management in the health care industry focusing on FDA/ISO134845 regulations to machine products.

Involved in registration audits in a variety of industries.(Aerospace, ISO and FDA)

Lead teams of project managers to help grow business for the client and increase the amount of automated machinery at the Manufacturing Plant.

Review medical devices to ensure that In Vitro Diagnostic Regulations are met.

At many times multiple projects are managed at once in various global locations.

Help clients with Lean Manufacturing and development and automation projects for medical devices.

Edwards Lifesciences

Project Manager (Engineering Manager)

Dec 2018 - Dec 2019

Cynet Systems, Irvine/CA,

Direct all Engineers in the department using Microsoft Project.

Ensure Quality Assurance steps were taken during the redesign phase.

Worked with stakeholders in Japan to develop In Vitro Diagnostic products.

Used Obyea practices to set up meeting areas where a dedicated room is used to meet and make important decisions related to the project.

Guaranteed the IVDR was compliant for all new products and redesigned products.

Verified that QMS requirements are met.

Alcon Laboratories

Quality Manager (QMS Director)

May 2018 - Dec 2018

Lake Forest/CA,

Direct all aspects of Quality Management System at the multiple company facilities.

Microsoft Project was used to track progress and update stakeholders on project status while using concepts like Obyea to set up meetings.

Quality management in the Research and Development of new products in the health care industry focusing on lean manufacturing.

Ensured FDA/ISO134845 regulations were followed for all products.

Use internal auditing procedures to measure the progress toward company goals.

Brandywine Incorporated

Director of Quality / Project Manager (AS9100/ISO9001/QMS Director)

Feb 2015 - April 2018

Brandywine Communications, Santa Anna and Tustin/CA,

Time and Frequency Solutions, Witham/United Kingdom

Direct all aspects of Quality Management System at the multiple company facilities.

Review and approve all legal contracts and Purchase Orders from customers (Boeing / Raytheon/Northrop Grumman / Lockheed Martin / SAAB).

Coordinated Six Sigma Black Belt Projects – Reduce Non Conforming Material

Developed and lead Green Belt Project to Improve the Inventory Tracking system

Used Microsoft Project to manage the merger and acquisition of Time and Frequency Solutions.

Managed Research and Development Projects for new Machine Design for Products.

Perform audits and coordinate Quarterly Management Review of Quality Meetings.

Develop continual improvement projects (automation) to lower overhead.

Lean Manufacturing and Risk mitigation conducted using Failure Mode Effect Analysis (FEMA).

Automated the Tooling /Fixtuering process for SMT Machine manufacturing.

Successfully implement projects regarding design and document control.

Johnson & Johnson

Project Manager (Change Control Project and China Supply Chain Director)

May 2012- December 2014

Johnson & Johnson- Advanced Sterilized Products, Irvine/CA

Project Manager for Project CLIP (China Labeling Implementation Project) which involved relabeling and bar-coding of all products entering the China market.

Coordinate projects in multiple countries and provide work stream reports to the China CORE team and lead multiple project management offices.

Used audits to track status of the project and maintain SOX requirements for corporate governance.

Manage projects on Change Orders and coordinate efforts between all departments.

Brought teams together and increased work flow through setting benchmark goals.

Implementing and training employees on new processes using automated systems.

Johnson & Johnson -Vistakon, Jacksonville/FL

Conduct Internal Audit Remediation project for high criticality and high complexity Change Requests (Level 4) while leading teams on Mechanical and Machine design projects which included the validation of automated product manufacturing.

Reduce overall open Change Requests in the electronic database (VIBES) system.

Worked to develop continual improvement projects with Engineering and Quality.

Review documents for major issues and provide training for those needed.

Strengthened Good Documentation Practices (GDP) and continual improvement.

Supported FDA audits and mitigation activities with corrective actions.

Processed Non-Conforming Material Reports to document problems identified.

Electro-Tech Machining, Long Beach/CA

Director of Quality / Production Manager (AS9100 & ISO9001 Project Manager)

Feb 2006 - May 2012

Head operations directing the company’s ISO9001 and AS9100 certification project.

Lead projects focused on Medical Device product development and design control.

Extensive experience in developing business solutions emphasizing quality control and production management using ISO Standards and Six Sigma methodology.

Create and review change requests/change orders for manufacturing and machine design for tooling.

Management positions included Production, Material, Shipping, and IT Departments for customers in Medical Devices industry and Aerospace.

Conduct interviews to understand risk involved in change requests.

Ensure Good Documentation Compliance and implement corrective actions.

Industries with experience include Medical Devices, Aerospace, Petrochemical, Semiconductor, and Advanced Ceramics.

Successfully completed multiple projects at once and ran several departments.

Worked on projects in FDA and ISO regulations environments.

Taylor Made Systems Bradenton/FL

Engineering Manager – Director of Canvas Systems (CAD Quoting Project)

Feb 2004 – Feb 2006

Increased overall operational efficiency through Total Quality Management and reconfigured the manufacturing operations to include the use of databases.

Developed and implemented standard operating procedures that optimized productivity and decreased labor expenses.

Helped implement the TQM and ISO9001 style of auditing for the company.

Created forms, tracking systems and weekly schedules for our engineering teams.

Expedited the prototype phase that substantially reduced development time.

Automated quoting system, supervised the CNC cutter (Gerber) engineering, and manufacturing process.

Responsible for all Pro-E and CAD software development

Write work instructions compliant to ISO 9001 standard

Managed projects on 2D and 3D product design using Pro-E and Solidworks.

Software Proficiency

Microsoft Project, Autodesk Suite, Solidworks, Pro-E, Verisurf, PC-Dimas,

Master CAM, Adobe Professional Suite, MS Office, Windows Server and C+

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