18 days old
2018-04-042018-05-02
  • Job Code
    611363
  • Payrate
    $45 To $50

We are looking for a QA Engineer for a position in Carlsbad, CA


Description:


Frequently interacts with complaint investigators, management, regulatory agencies, company market representatives, and customers, and/or functional peer group managers regarding incident reporting matters


Writes MDRs/MIR reports and submit to the necessary authorities


Work with complaint investigators to prepare responses to address Competent Authority inquiries


To succeed in this role, you should have the following skills and experience:


Timeliness of incident reports (MDR, MIR, others)


No-major non-compliance in applicable process/records.


Good Verbal and written communication skills


Analytical skill and focus on detail


Teamwork in and outside Q&R


Experienced in eMDR reporting


Experiences in reporting tools (Trackwise, SAP)


Conflict resolution


Fluent in English (verbal and written)


Problem Solving, working independently with Minimum supervision,


Handles complex Vigilance Reporting responsibilities relying on judgment and experience to determine best course of action


4+ years experience Medical Device and or other regulated industry (Pharma, IVD, ).


Basic knowledge of QSR, 21 CFR part 803, ISO13485, ISO9001, etc.

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QA Engineer

Randstad Technologies
Carlsbad, CA 92011

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QA Engineer

Randstad Technologies
Carlsbad, CA
US

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