SUMMARY

• To work in a Quality Assurance/Regulatory Manager role in which she can contribute her Medical Device skills and goal setting skills to DELIVER high quality RESULTS to your organization.
• Responsible for leading and managing a Medical Device Development & Labeling team through developing, planning and executing to her AUTHORED Validation Strategies, Project Plan and Verification/Validation Plan for Medical Device System Verification activities along with preparations for 510k submissions.
• In depth knowledge of regulations to make informed judgments and propose creative solutions.

PROFESSIONAL EXPERIENCE

Confidential

Project Manager

Responsibilities:

• Main responsibilities are planning, developing Project/Validation Plans and validating Medical Devices in the Regulatory Affairs.
• Responsible for leading and managing a Medical Device team through developing, planning and executing to the Project/Validation Plan for the Labeling and validation of Dialysis machines.
• Managing scope and direction of projects to implement projects according to project scheduled launch implementation dates.
• Projects are defined as Validating Medical Dialysis Machine auxiliary components and device labeling.
• Builder of work plans which are comprehensive and require conjunction coordination and planning with other departments for project support.
• Responsible for coordinating regulatory testing activities including devising plans of operations for the launch of New Product development.
• Excellent strategic planner, defining project main goals and specific objectives.

Confidential

Project Manager

Responsibilities:

• Achieved results in implementing an array of complex accelerated projects prior to deadlines. Solved business challenges by driving initiatives with excellent organizational planning skills and structured execution of projects. Led high performance Project teams, Managing Program Managers, Sr. Project Managers, Business Analysts to drive SDLC project implementations and separation results. Developed and drove Project Plans aligning project tactics with project strategy. Led PMO initiatives for strategic Enterprise Separation Initiatives through collaborations with over 200 System Owners.
• Led, coordinated, facilitated, motivated project resources to gain alignment on project goals and objectives.
• Facilitated and led effective project meetings, managing change and conflicts and developed resource planning to manage project workloads and productivity.
• Implemented a versatile array of regulatory systems ranging from Medical Device Submission systems to systems essential for patients. Accomplished results for implementing projects through the production of deliverables such as Change Requests, Functional Requirement Specifications, Data Privacy Plans, Data Migration Plans, Project/Validation Plans, Design Deliverables and System Certifications. Liaison, go to expert for the Review Board for Regulatory support and advice for Project Implementations.
• Led the development and provided mentoring for the execution of CAPA’s and CAPA policies/procedures.
• Accountable for Project Management responsibilities along with providing SLC mentoring and training and approvals of the following deliverables: Change Requests, Supplier Quality Operations, Functional/User Requirements, Traceability Matrixes, Project/Validation Plans, Design Deliverables, Project/Validation, Test Protocols, Data Migration Plans, Decommissioning Plans/Reports/Summaries, Configuration Item Inventories & System Certification Summaries for Software, Infrastructure and SAP.
• Invented, implemented & launched an organizational system to save time, increase productivity of onboarding of new staff acclimation with SLC and concurrently increase department sales within the organization. Proposed and implemented a pro - active challenge solving system planned to increase sales in the organization from ~$124,000 to a potential increase to $500,000 and beyond based upon the frequency of implementation. Resulted in the approval of Senior Management along with support of implementation.
• Solved complex SLC challenges through solution creation and implementation through team collaboration and methodical approaches.
• Assessed projects to increase effectiveness and reduce costs where necessary while maintaining compliance.
• Contributed an array of continuous improvement initiatives, which led to multiple enterprise process improvements.

Confidential, Clearwater, FL

Process Engineering Consultant

Responsibilities:

• Devised Change Requests along with Project Plans, Validation Plans, Functional Requirements and Test plans in order to comply with policies and regulations
• Constructed a Gel Melting Test for the Gel Melters, which processed Advil Gel Capsules, and a Sprayball coverage test to ensure proper cleaning for the Gel Melting Vessels. Analyzed and red-lined Engineering Drawings of the Mixers and the Gel Melters to ensure they were accurately drawn with the addition of new components
• Identified instruments that required repair, which resulted replacement of pressure gauges located on the Gel Melters

Confidential - South Haven, MI

Validation Consultant

Responsibilities:

• Wrote and executed Installation Qualifications, Operational Qualifications, and Performance Qualifications along with Utilities Validation protocols.
• Coordinated execution schedules and activities with departments’ heads along with staff equipment owners to ensure validation goals were reached.
• Provided guidance to the chemical operators and compliance engineering departments regarding feasible validation procedures.
• Tracked validation activities to ensure that validations were closed out ahead of schedule
• Validated several high volume reactors, tanks, heat exchangers, dryers, scales and mills for the processing of the intermediates for heart medicine
• Provided validation oversight by reviewing SOPs, validation reports and deviations