Rina Parikh Email & Phone Number

North Chicago, Illinois, Us

Manage the Non-Conformance Reports (NCR) and Corrective & Preventive Actions (CAPA) process for the manufacturing site.• Provide guidance to the NCR and CAPA investigators. Ensure investigations are thorough, focused on comprehensive root cause determination, and factually written.• Provide Root Cause Analysis and TrackWise (TW)system training to CAPA and NCR users. • Influence and collaborate with Quality, Manufacturing, Regulatory, Medical, Tissue Services, and R&D to resolve quality issues. • Utilize strong negotiation skills to determine product disposition, and ensure corrective actions are appropriate to eliminate the root cause and prevent recurrence while meeting all applicable regulations (21 CFR 820.90, 21 CFR 820.100, ISO 13485, 21 CFR 1271, AATB Standards for Tissue Banking). • Lead efforts for timely closure of CAPA and NCR. • Facilitate and Lead biweekly CAPA Review Board and monthly CAPA System Review meetings. Review quality issues and adverse trends from product and process monitoring, complaints, NCR, and CAPA. • Analyze, prepare, and present NCR and CAPA data in the site Quality Systems Management Review Meetings (QSMR). • Represent manufacturing site in the company CAPA Expert Council and services as a co-Business Process Owner for CAPA. Assist with CAPA System Integration activities including TrackWise workflow design & system testing, training material development, and procedure updates. • Provide Subject Matter Expert (SME) support during Regulatory Agencies inspections, Corporate & Site Internal Audits. • Coach and oversee other CAPA Analysts in the team.

North Chicago, Illinois, Us

Investigate customer complaints, evaluate for Adverse Event (AE) reporting determination, submit AE reports to Regulatory Agencies and Notified Bodies.• Review records entered in Track Wise (TW) complaint module to assess for accuracy and make determination if the record meets complaint definition per 21CFR820. • Evaluate complaints for risk and complete AE reportability decision tree in accordance with applicable regulations (21 CFR 803, 21 CFR 1271, EU Medical Device Directive, Canada SOR/2007-118) and internal policies. Submit AE reports to FDA, Health Canada, and Notified Body.• Perform risk evaluation and relevant investigation steps necessary to prepare and submit Adverse Event Reports to the designated Regulatory Agencies and Notified Bodies.• Investigate customer complaints in accordance with 21 CFR 820.198. Perform complaint history review, complaints sample evaluation, Device History Record (DHR) review, and coordinate examination of complaint related tissue specimen with Histology and Medical Director.• Assist with Annual Reportable Malfunction & Injury List (RMILs) review with Medical and Quality Engineering.• File Biological Product Deviation Report (BPDR) in accordance with 21 CFR Part 600.14• Provide training to newly hired Complaint Analysts.• Support TrackWise complaint module upgrade by performing software testing of changes and provided relevant training to the team members.• Provide Subject Matter Expert (SME) support during Regulatory Agencies inspections, Corporate & Site Internal Audits. • Analyze, prepare, and present Complaints & AE data in the site Quality Systems Management Review.

Franklin Lakes, New Jersey, Us

Investigate customer complaints, evaluate for FDA Medical Device Reporting (MDR), submit MDR reports.• Review customer complaints to ensure complaints are recorded in accordance with 21 CFR 820.198. If needed, reach out to customer service / complaint coordinators to obtain required information. • Evaluate complaints for FDA MDR reportability per 21 CFR 803. Complete and submit FDA 3500A MDR Initial and Supplemental reports.• Conduct detailed preliminary investigation on return complaint sample. Coordinate further investigation by Manufacturing sites and contract Manufacturers/Suppliers.• Experience using Micrometer, Water bath, Microscope, Vernier caliper, Balance, Comparator, FTIR, Instron.• Perform data query in Complaint Management System and prepare complaint data analysis/summary reports to assess the need for Health Hazard Evaluation (HHE). • Analyze, prepare, and present Complaint and Adverse Event trend data for Post Market Surveillance meetings. Perform FDA MAUDE, Medical Device Recalls, and Warning Letter database searches.• Train Complaint Analyst in complaint handling/complaint evaluation procedures. • Write/revise Standard Operating Procedures related to Complaint Handling and MDR reporting. • Assist Regulatory Compliance during Regulatory Agency Inspection, Corporate & Internal Audits.

B. S., Computer Science

B. S. Microbiology (Minor Chemistry)

Cqe 2018

Ctbs Certification

Complaints, Mdrs And Reports Of Removals & Corrections And Recalls

Aami Quality System Requirements And Industry Practice

B. S. Microbiology (Minor Chemistry)