Clinical Investigation Engineer | Israel

Job Title: Clinical Investigation Engineer 

Location: Caesarea, Israel

Department: Quality Assurance

Reports to: Complaint Handling Unit Manager

Job Description: The Clinical Investigation Engineer effectively implements the complaints handling process, performs clinical analysis to determine the cause of failures and responds to the field. Based on clinical knowledge, processes complaints in a uniform and timely manner according to regulatory and company procedures.

Key Responsibilities & Authorities:

  • Understand the underlying technology of the products.
  • Document and maintain records of all complaint investigations and clinical analysis in accordance with 21 CFR § 820.198 and ISO 13485:2016 8.2.2
  • Develop, prepare, and analyze trend reports for complaints; monthly or quarterly as required.
  • Communicates results with internal departments, i.e., Product, R&D, RA, and Clinical.
  • Complete all required customer complaint related documentation in an accurate, professional and timely manner.
  • Provides input from PMS to risk management and CAPA.
  • Actively pursue answers and updates from subject matter experts.
  • Investigate specific events by contacting internal resources, field personnel and/or physicians/Customers as appropriate.

Authorities:

  • Performs initial reportability assessment for complaints in accordance with 21 CFR § 820.198 and ISO 13485:2016 8.2.2.
  • Performs clinical analysis and determines cause of failures

Experience Requirements:

  • 2+ Years previous complaint handling experience
  • 2+ years experience in Regulatory Affairs and/or Quality Assurance in medical devices

Education:

Bachelor’s degree in scientific area - Must.

Job Specific Skills (Languages, SW, systems, etc.'):

  • Excellent verbal and written communication skills (Hebrew and English).
  • Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems, experience with Salesforce – Preferred.
  • Written and verbal communication skills.
  • Ability to work with a sense of urgency.
  • Orientation to details.
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions.

Working Relationships:  
Internal: SCR’s, Service, R&D, RA, Supply chain, Clinical Product
External: global distributors, auditors

 

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The website was last updated : 26 Nov 2018

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