Nickea Pittman Email & Phone Number

California Area

Provides training, procedural development and consulting in using Statistical Applications for data analysis, process improvement, experimental design and and Verification and Validations. Specializing in process improvement with statistical methods, data analysis, design of experiments, regression, measurement system analysis and reliability.

Rochester, Minnesota Area

Supporting of Process Validation activities at Bard Medical facility in Stewartville Mn. • Support Qualification and validation of manufacturing, packaging processes as well as corresponding test methods and software applications for catheters and disposable products. • Facilitate and author MVP plan for existing products and line expansion projects. Lead in process characterization and development of process mappings.• Review and approve process validation protocols and reports as well as evaluation appropriateness of statistical rationale.• Lead in design of experiments, and support of process failure investigations, root cause analysis and corrective/preventive actions (CAPAs). • Facilitate and co-author process failure mode effects analysis (pFMEAs) as well as evaluation of process controls for adequacy.• Establish and validate test methods in support of product design and remediation activities.

Ft Lauderdale

• Systems and configuration administrator for Quality Systems software applications used to maintain the device history records and other software platforms within Customer Support• Working with stakeholders (e.g., System Administrator, IT personnel, system/process owners) on requirements definition in order to define test scenarios and strategies • Identifying potential risks in the planning, development, implementation, and maintenance of a software application and assisting in creation of mitigation strategies and contingency procedures • Analyzing and writing requirements, test protocols and test reports for off the shelf software packages. • Writing work instructions for software use, as well as other technical documentation, procedures and policies. • Designing software validation plan, test plan, traceability, and validation report documents • Assuring appropriate test coverage in accordance with operating procedures and regulatory requirements • Ensuring the accuracy, completeness and compliance of document deliverables • Providing technical support and guidance to personnel utilizing validated software • Participating in change control process, involving Suppliers, revising test specifications and validating changes to ensure that changes are correctly incorporated in the software products • Work with Quality Director to expand OTS software validation process & generate procedures• Perform/Support internal audits of Customer Support activities, and address findings• Investigate and implement solutions for CAPAs owned by Customer Support• Initiate and drive resolution of SCARs as needed• Serve as QA representative on Customer Support projects as needed – offer guidance/review documents from a QA perspective, generate documents such as requirements, risk analysis, DIVVM/traceability matrices, protocols, reports, process validations, etc.• Lead Customer Support projects as needed – create plans, drive execution, and communicate on progress

Saginaw, Michigan Area

• Developed a validation policy necessary for driving validated effectiveness for a medical device supplier.• Evaluated, assessed and revamped current validation approach and procedures.• Brought forth a phased project based approach to develop a master validation strategy based on the requirements from ISO 13485 and CFR 820.• Effectively delivered the entire engagement to ensure goals are documented and achieved.• Clearly communication during all phases to avoid needless cost overruns.• Provided continued compliance after efforts including sustainability training program to ensure a quality product in the market.

Various

Consulted with the following companies: Cardinal HealthNoven PharmaCordis Beckman CoulterWatson PharmaceuticalsBoston ScientificAzo PharmaPhysio Control• Planned and executed Process/Product change activities scoping Design Verification to Process Validation. • Demonstrated technical written skills in development of numerous IQ, OQ and PQ protocols and reports, Process Setting Verifications, Test Cases & Software testing documentation. • Designed and implement shipping and packaging component containers for products to other facilities, including packaging validation protocol reports, design of packaging and drawings. • Test Method Validations, Quality Sampling Plans, and Defect Characterizations for Variable and Attribute product specifications.• Development of studies using Gage R&R statistical techniques for equipment test methods.• Created Master Validation Plans and Traceability Matrix for improvement of Quality Systems. • Responsible for oral and written of presentations before the board of directors as the project lead.• Development of Process Controls, Process Flow charts and Work Instruction.• Carried out Regulatory/ Quality tasks such as FMEAs risk based assessments, Gap analysis, Supplier Audits, Retrospective Validations. • Coordinator of Supplier Quality / First Article Inspections with Outside Vendors and Purchasing departments.• Use of Design of Experiments (DOE) testing for new product design change and Root Cause Analysis, Ppk analysis, sample size determination, and normality assessments using Minitab.• Supported project activities though creation of Design/Process Change Assessments, aging studies, new product specifications. • Experienced with software validation execution and template development for Laser profiler and other PLC and software based equipment. • Retrospective validations, supplier quality audits and historical data statistical analysis of process capability and reliability.

Miami/Fort Lauderdale Area

Rotational Internships at the Diabetes Research Institute, VA Hospital and Rosensteil Medical Research. • Designed a bioreactor for stem cell research including construction of computerized image design. • Assisted design team to modify/enhance/finalize design layout and developed the procedures for assembly.• Conducted calibration techniques for continual media flow bioreactor device using permeability calculations in agarose gel to determine cell differentiation and chondrogenesis during actual experimentation. • Developed a method to perform islet cell transplant analysis using calorimetric –voltage instrumentation. • Used insulated gold plated chambers to culture islet cell and to measure the electrical conductivity to determine the performance of transplant tissue.

Miami/Fort Lauderdale Area

• Assisted Quality Assurance Team performing failure analysis of non-conforming product including balloon catheters and stents. • Implemented and executed a formal medical device training program for technicians. • Bench marketed companies with designed program to meet their requirements along with quality results. • Responsible for organizing training material for each individual technician utilizing database tracking system. • Performed research on the decontamination of used balloon catheters and stents to identify potential re-use.

Biomedical Engineering, Mechanical Engineering, Honors

Master Of Business Administration (Mba), Finance