Hello,
Hope you are doing well. I Have the following Urgent Opportunity, please review the below need and let us know if you are available and interested.
Job Title : QA Engineer with Medical Devices experience
Duration : 3 -12 months
Location : Aloha, OR
Local candidates are strongly preferred – but not required.
Primary Skill: ANALYSIS; PROJECT MGMT
Other Skills: CUSTOMER SERVICE; MEDICAL TERMINOLOGY; MS Office
Roles & Responsibilities
Years of Experience & Expertise Level: Mid level 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
- Direct experience with definition of Design for Supportability requirements/ roadmap
- Experience with Agile/ AgileMD work flow development
- Project management
Thanks and Regards
Baachi
Resource Manager,
Direct: 510-250-7616, Alt Ph: 510-250-7617
EFax: 510-578-1309
Yahoo IM: baachi_hr
Gtalk IM: ziplogicbaachi
We help our clients, employees & partners compete and win!
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