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.
• Lead efforts for timely closure of CAPA and NCR.

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..
• 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.
• Assist with Annual Reportable Malfunction & Injury List (RMILs) review with Medical and Quality Engineering.

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).

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)