Below are some key highlights of position
Project Details:
Job Title:
Quality Specialist II
Role:
West Hills CALIFORNIA 91304 United States
Contract:
12+ months with possible extension
Education:
* Bachelor’s degree, preferably in Biology, Chemistry or Engineering or equivalent related experience 2+ years of overall experience in Manufacturing,QualityorEngineering
Job Description:
Must have skills:
Complaint investigation, 13485, IVDR, IVDD, MDR, MDD,
- Track all stages of the Complaint Documentation process including: Data Analysis, Reporting and Trending, Documentation Review, Coordination of complaint and lot qualification data, Device history reviews, Review and closure of certain categories of complaints. * Maintain accurate documentation and files related to special projects, complaints and lot Qualification.
- Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
- Support database development and reporting capabilities related to the complaints as needed.
- Support review and investigation of adverse events for Post Market Surveillance Reporting.
- Perform basic product review and failure analysis.
- Lead and/or participate in product related team meetings and/or performance reviews, as needed.
- Prepare risk management plan, facilitate risk analysis and assessment per Risk Management Policy, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, PERs, PCRs, recalls, scientific literature searches, clinical performance, and proficiency testing
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