QA Engineer III

Title: QA Engineer III
Location: Carlsbad CA
Duration: 9 MOnths Extendable

Description: 
Frequently interacts with complaint investigators, Philips management, regulatory agencies, Philips 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. 

Thank you,
Sachin Patil,
510-574-7988
sachin@apninc.com

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