Medical Device Quality Engineer

Elson Young

Mobile Phone: 510-***-**** ● Email: **********@*****.***

Objective

Highly experienced Quality Assurance professional seeking a position in an organization where I can utilize my skills, experience, and knowledge towards FDA and Regulatory Compliance. Summary of Qualifications

11+ year experience in various roles in Quality Assurance.

Support CAPA and Non Conformance processes.

Provide training for new employees.

Over 10 years experience in complaint handling.

File Medical Device Reports (MDR) when required.

File European Union (EU) Vigilance Reports when required.

Familiarity with, EN ISO 13485 2012, Health Canada/CMDR Requirements, European Directives IVDD/MDD, FDA’a Quality System Regulations (QSR), 21 CFR 820.

Maintenance of Complaint log, MDR Log, and Vigilance Log.

Organize complaint review committee to review complaints.

Develop Complaint Metrics for Management Review.

Startup company experience.

Supervisory experience.

Career History

09/2017-Present ThermFisher Scientific Fremont CA

Develops and formulates Assays and Controls to test for Drugs of Abuse Senior Quality Specialist

- Managed the customer complaint process

- Mentor two junior complaint handler

- Sent responses to customers

- Generate daily complaint metrics for Senior Leadership Team for review.

- Generate and present complaint metrics for management review

- Assist in CAPA processing

- Primary contact for all customer complaints

09/2016-03/2017 (Contract) Transcend Medical Menlo Park, CA Develops and commercializes devices to treat Glaucoma Complaint Manager

- Managed the end to end process of customer complaints including review and maintenance of complaint files.

- Sent responses to customers.

- Primary contact for all customer experience reporting and complaint handling activities related to commercial.

- Responsible for independently receiving, documenting, investigating and coordinating responses on product complaints.

- Ensure timely investigation of and response to product complaints.

- Collaborates with Quality Assurance, Sales Personnel, Customer Service, Engineering, Manufacturing, and Clinical Affairs.

- Maintains current and complete complaint files.

- Performs collective analyses of product complaints and implant reports for trends and identification of potential corrective or preventive actions. Elson Young Page 2

03/2016- 05/2016 (Contract) Stryker Fremont, CA

Develops and commercializes devices to treat brain aneurysms Quality Analyst

- Evaluate complaints for MDR requirement.

- File Medical Device Reports (MDR) when required.

- File European Union (EU) Vigilance Reports when required 12/2013-02/2016 Optovue Fremont, CA

Develops and commercializes device that provides physicians with advanced tools for retina diagnostic capabilities.

Quality Complaint Investigator Lead

- Streamline the Complaint Process.

- Generate monthly Quality Complaint Metrics and present them monthly in Complaint Metrics meetings.

- Train and mentor other Complaint Specialist.

- Generate daily work assignment.

- Evaluate complaints for MDR requirement.

- File Medical Device Reports (MDR) when required.

- File European Union (EU) Vigilance Reports when required

- Responsible for maintaining the Complaint log, MDR Log, and Vigilance Log.

- Develop Complaint Metrics for Management Review. 11/2013-12/2013 (Contract) Novartis Emeryville, CA Develops and commercializes a blood monitoring system for blood banks. Quality Assurance Analyst II

- Investigated product complaints by coordinating with internal resources, field employees, and international staff as appropriate.

- Close Complaints

05/2012-08/2013 OptiMedica Sunnyvale, CA

Develops and commercializes a reproducible, noninvasive technique to replace the inconsistent manual steps in cataract surgery with femtosecond laser technology. SENIOR QUALITY SPECIALIST

Champion the Complaint Department (Subject Matter Expert)

- Managed a group of complaint handling specialist.

- Trained field personnel regarding the complaint process.

- Evaluated complaints for MDR requirement.

- Wrote and Submitted MDR to the FDA when required.

- Filed European Union (EU) Vigilance Reports when required

- Responsible for maintaining the Complaint log, MDR Log, and Vigilance Log.

- Developed Complaint Metrics for Management Review.

- Streamlined the Complaint Process.

- Investigated product complaints by coordinating with internal resources, field employees, and international staff as appropriate.

- Supported CAPA system

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02/2012-05/2012 (Contract) Sonitus Medical San Mateo, CA Develops and commercializes a non surgical and removable prosthetic device that relies on bone conduction to imperceptibly transmit sound via the teeth QUALITY ASSURANCE SPECIALIST

- Responsible for incoming inspections.

- Review and approve of Lot History Records.

- Review and approve of packing lists prior to shipping.

- Facilitate Material Review Board.

- Perform review of final assemblies.

- Investigate returned products and perform root cause analysis.

-Close complaints in a timely manner.

-Attend complaint meeting to determine MDR qualifications and determine complaint 01/2012-02/2012 (Contract) ACCURAY INC Sunnyvale, CA Develops and commercializes a high precision radio surgical medical device to treat cancer patient worldwide-US, Europe, Asia, and South America. REGULATORY AFFAIRS SPECIALISTS

- Evaluate complaints for MDR requirement.

- Communicate with Field Service Engineers to gather more information.

- Close complaints.

07/2008-12/2011 DFINE Inc. San Jose, CA

Develops and commercializes class 2 medical device to treat vertebral compression fractures worldwide-US, Europe, and South America.

SENIOR COMPLAINT HANDLING SPECIALIST

- Responsible for managing the complaint department.

- Evaluate codmplaints for MDR requirement.

- Filed Medical Device Reports (MDR) when required.

- Filed European Union (EU) Vigilance Reports when required

- Responsible for maintaining the Complaint log, MDR Log, and Vigilance Log.

- Developed Complaint Metrics for Management Review.

- Investigated product complaints.

- Performed root cause analysis of returned products.

- Communicate with Sales Rep. to gather more information.

- Send physicians Complaint Acknowledgment and Response Letters.

- Set up and maintain the complaint investigation laboratory.

- Organize complaint review committee to review complaints.

- Performed DHR reviews.

- Performed Quality Release Testing.

- Provided Support to CAPA System

12/2006-06/2008 HemoSense Inverness Milpitas CA

Developed and commercialized handheld medical device that monitors blood coagulation factor. COMPLAINT HANDLING SPECIALIST

- Evaluated complaints for MDR requirement.

- Reviewed, approved, and closed complaints.

- Filed MDR as necessary.

- Performed root cause analysis of returned products.

- Trained new complaint handling specialists.

- Assured timely completion and database input of complaint investigations.

- Performed complaint trend analysis and report metrics to senior management on a regular basis.

Elson Young Page 4

08/2004 to 11/2006 Abbott Diabetes Care Alameda, CA Developed and commercialized a handheld device that monitors blood glucose levels. COMPLAINTS EVALUATOR I

- Evaluated customer complaints.

- Evaluated complaints for MDR requirement.

- Utilized software applications, computers and databases to maintain files.

- Generated daily report to discover which cases needs to be sent a 30 day letter.

- Handled multiple tasks effectively and efficiently. 01/2003 to 08/2004 Boston Scientific Smart San Leandro, CA

(Formally known as Smart Therapeutics)

Developed stents for the treatment for brain aneurysms. QUALITY INSPECTOR LEAD, (ACTING SUPERVISOR)

- Oversee the daily tasks and responsibilities of a team of quality inspectors.

- Developed inspection schedules for all the inspectors.

- Reviewed and released DHR.

- Leader of the Stent Loading group, which is part of the Company’s Continuous Improvement Team (CIT).

- Coordinated Material Review Board.

- Performed internal audits.

- Administer training for new inspectors.

- Performed root cause analysis on products that failed. 07/2001 to 12/2002 Smart Therapeutics San Leandro, CA

(Acquired by Boston Scientific) Developed stents for the treatment for brain aneurysms. QUALITY INSPECTOR

- Performed inspections on incoming raw materials.

- Inspected stents, stabilizers, and catheters.

- Proficient with the use of various hand-held measuring tools as well as Stereo and Toolmakers, Microscope, Smartscope, FineScan, Z-Mike, See Mic, and Chatillon. EDUCATION:California State University, Hayward - Bachelor of Science, Kinesiology, June 1998

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