Medical Device Regulatory Specialist/Complaint Coordinator Resume CA - Hire IT People

SUMMARY

Creative, result oriented Mechanical Engineer with broad experience in mechanical, electromechanical, and instrument engineering.
Expertise based on experience in complaint investigation, failure analysis, technical support in the areas of medical device development, manufacturing, service and maintenance.

AREAS OF EXPERTISE INCLUDE:

PROFESSIONAL EXPERIENCE

Confidential,CA

Medical Device Regulatory Specialist/Complaint Coordinator

Responsibilities:

Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803Medical Device Reportingand 806 Corrections and Removals.
Drive the resolution of product issues in the field, through coordination ofinvestigations, CAPA process, recommending customer bulletins, etc.
Document and maintain records of all complaint investigations in accordance with 21 CFR § 820.198 including failure analysis follow - up.
Present customer complaint investigation facts and details to management for those complaints that may have a potential safety impact.

Confidential, Menlo Park, CA

Service Engineer

Responsibilities:

Performed all the actions of Complaint Investigation Process for Vascular Positioning System (VPS) Consoles returned due to customer complaints for investigation: complaint verification/reproduction, diagnostic/troubleshooting, root cause analysis, corrective and preventive actions (CAPA), Complaint Investigation Report.
Coordinated and performed all the steps of Service Process for VPS Consoles returned for regular service: testing/performance verification, diagnostic/troubleshooting, repair/replacement of components, software recovery and/or upgrades, Service Report.
Represented Service Department during ISO-13485 and FDA audits.

Confidential, Santa Clara, CA

Quality Engineer,

Responsibilities:

Contributed to all stages of Complaint Investigation Process for returned CELL-DYN Hematology analyzers - Abbott’s automated hematology analysis systems;
Initiated and developed detailed plan for Complaint Investigation in each specific case based on evaluation of the complaint data and returned hardware, historical analysis of the complaint within Complaint Investigation Database, R&D and Advance Engineering departments’ records;
Executed the developed and approved plan of investigation that typically included installation and initialization of the returned equipment, testing/reproduction/verification of the issue of the complaint, diagnostic/troubleshooting, root cause analysis, corrective and preventive actions (CAPA) initiation;
Generated detailed Complaint Investigation Report that included Customer Complaint Response Letter;
Provided technical expertise on the hematology analysis systems, various related technical issues such as testing of returned materials, test equipment, etc. to other investigators of the Complaint Investigation Department.

Confidential

R&D Engineer, Electronics

Responsibilities:

Participated in a wide range of R&D projects to improve controlling systems of metallurgical production processes by implementing numerical simulation models of the processes and apparatus;
Executed long-term and full-scale tests of various prototypes in the field;
Performed statistical data analysis of the test results.