BEE-0924104- QA Engineer with Medical Device Industry exp

Hi,

      This is Vysham from Sriven Infosys Inc, looking for consultants for below requirements.

 

Local candidates are strongly preferred.

Phone screen followed by In-person interview
Need two professional references from recent projects
Need I-797 or VISA copy

Title: QA Engineer with Medical Device Industry exp
The length is 3 -12 months
location is Aloha, OR

Years of Experience: 5 years in Medical Device Industry.

Project Description:
Product Support and Complaint Handling Engineer/ Specialist

Daily Responsibilities:
-Support Medical Device Complaint Handling process
. Initial evaluation of product issue reports
. Maintain complaint files
. Coordinate complaint resolution activities
. Maintain Complaint handling Standard Operating Procedures (SOPs)
. Issue trend analysis and reporting
-Work with call center agents and engineers to improve data capture and reporting processes
-Work with Support Eng and Development Eng to identify and drive supportability enhancements to Digital Health Group products
-Author customer notices, service bulletins

Necessary Skills (Must Have):
-Product Support experience in regulated Medical Device environment. (FDA 21 CFR Part 820, ISO 13485)
-Customer Support experience with complex networked products
-Engineering degree (electrical, biomedical, information technology)
-Demonstrated analysis and problem solving ability, working knowledge of statistics, risk analysis processes, structured problem solving

Additional Skills Desired (Nice to Have):
-Direct experience with definition of Design for Supportability requirements/ roadmap
-Experience with Agile/ AgileMD work flow development
-Project management

Primary Skill:	ANALYSIS; PROJECT MGMT
Other Skills:	CUSTOMER SERVICE; MEDICAL TERMINOLOGY; MS Office

 

 

Thanks & Regards
Vysham
Technical Recruiter
Sriven Infosys INC
Voice : 212-999-6251 Ext: 219
Alt : 646-644-2894
Fax :212-658-9460
vysham@sriveninfosys.com

IM: vysham2501@yahoo.com;

vysham.sriveninfosys@gmail.com;
www.sriveninfosys.com

 

Sriven Infosys Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, citizenship, disability, age, military or veteran status, and other characteristics.
We help our clients, employees & partners compete and win!

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