Reena Rai Email & Phone Number

Deerfield Beach, Florida, Us

Owner/Franchisee of multiple childcare facilities providing excellence in early childhood education.

New Brunswick, Nj, Us

North America Source Quality - External Manufacturing Site Management

New Brunswick, Nj, Us

Provide expert evaluation, investigation and closure of medical and product quality complaints within a timely and accurate manner including field sample evaluation. Collaborates with internal and external sites and must have expert knowledge of products and manufacturing processes.Recognize when issues need to be escalated, quickly detect and analyze trends, and identify gaps to drive process improvement in collaboration with the Medical Safety, Site Quality groups and the Third Party Manufacturing Group. Facilitate/coordinate and lead various projects within the department independently, communicate effectively with all levels of management (internally & externally), and conduct training sessions with complaint systems.Analyze data and other trends, and present/report to senior management.Manages interfaces with other organizations for purposes of investigating serious medical and product quality complaints.Partners with organizations such as marketing, franchise quality, medical safety, Consumer Care Center, and external business partners to ensure the integrity, consistency, compliance, and alignment of the complaint vigilance process.Drives issues to resolution, makes the complex clear, identifies complaint vigilance issues and gaps, recommends resolutions, and ensures cross-function/organization alignment by defining and leading projects that address stakeholder requirements.Audit complaint records to ensure standard processes are being followed, and complaints are closed as required. Engage in other quality systems (CAPA/NC) as required to address non-conformances and trends. Responsible for complaint closure metrics, support internal and external audits and inspections, and provides training, guidance, and supervision to more junior team members.

New Brunswick, Nj, Us

• Triage and evaluate product quality complaints and perform an assessment in accordance with Standard Operating Procedures using the Product Quality Management System (PQMS).• Review events reported, determine the defect category, perform critical assessments, trend frequency to detect trends, recover field samples for evaluation, follow-up with complainant, and ensure timely communication to management.• Collaborate with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling.• Develop training and deliver to colleagues and partners.• Work independently, challenge the status quo, identify gaps and drive process improvements using Process Excellence tools.• Audit Complaint Records in PQMS to ensure standard process is being followed and complaints are closed as required.• Compile product and lot-specific complaint trending data and complaint closure metrics as requested. • Support internal and external audits and inspections.• Evaluate and assign complaints to sites/affiliates.• Compile quarterly management review boards as requested.

Princeton, New Jersey, Us

Quality plans, risk assessments, validations, OOS, Non-Conformance Investigation, CAPA, Stability Studies

Princeton, New Jersey, Us

In process and finished goods testing, stability program management, investigations, validations

Largo (Tampa Bay), Fl, Us

• Manage various project teams (10+ members) for new product updates/launches following the product realization method.• Liaise with medical research collaborators at hospitals and universities. • Support and train a 32 member sales force for related issues.• Work with marketing team to create relevant marketing materials for sales force as well as internal company.• Manage and run customer preference studies for initial product launches.• Maintain a descriptive and detailed product portfolio for various projects.• Evaluate problems, propose solutions, and design new methods of data acquisition, analysis and interpretation. • Field problems and issues that occur during research studies. • Perform design verification and validation for studies.• Travel to field sites as a company representative to troubleshoot, convert, and/or assist end user with products.• Collaborate with subcontract manufacturers (nationally and internationally) to bring down costs of products.

Princeton, New Jersey, Us

• Oversaw the management and maintenance of laboratory equipment, ensuring that equipment is properly calibrated following manufacturers instructions.• Trained other lab personnel how to use lab equipment.• Highly skilled with HPLC, Instron, UV-Spectrometer, DSC, GC, and other analytical tools.• Performed data collection and analysis support for neurological research programs and product development (burn patient care applications). • Developed study protocols for test purposes.• Prepared technical reports, patents, publications, and proposals for new innovative technologies. • Evaluated equipment for safety, efficiency, and effectiveness. • Worked with the regulatory departments to ensure project specification met the appropriate standards (validation stage). • Assembled prototypes, equipment, and tested samples.• Experience in wound care and orthopedics.• Compile data into an organized spreadsheet utilizing the Microsoft Office Suite.

Princeton, New Jersey, Us

• Trained on multiple analytical test methods• Conducted various analytical tests on numerous medical device products• Assisted in the creation of various medical devices within the Product Development group

• Solved difficult equations regarding enzyme kinetics• Did personal research to gain knowledge of the field

Washington, D.C., Us

• Entered relevant data for outgoing mail• Maintained a 98% accuracy• Consistently exceeded the required goal for processing mail

Bs, Biomedical Engineering

Supervisor Certification, Operations Management And Supervision

Quality Management Certification, Quality Management

Quality Systems Regulations, 21 Cfr Part 820

Ms, Biomedical Engineering