CAPA Specialist | Israel

Job Title: CAPA Specialist

Location: Caesarea, Israel

Department: Quality Assurance

Reports to: QA Director

Job Description: This position has the responsibility and authority to provide technical support to all areas of Mazor Robotics by facilitating the Corrective and Preventive Action system (CAPA), including providing input, organizing and analyzing the data and managing actions.

Verify the implementation of the policies and procedures described in the documented quality system related to CAPA. Coordinate CAPA process to ensure corrective/preventive measures are documented, implemented and measured for effectiveness. Develop, maintain, and communicate metrics on the CAPA system. Participate in process improvements.

Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Key Responsibilities & Authorities:

  • Manage CAPA activities and documentation to assure compliance with CAPA policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
  • Lead the cross functional teams to provide investigations of product quality issues and process deviations.
  • Provide guidance and expertise to ensure detailed CAPA Root Cause Analysis. Apply problem solving techniques to problems of various scope and complexity.
  • Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
  • Generate CAPA metrics.
  • Recommend and implement product quality and process improvements. Provide written reports and supporting documentation for investigations.

 

Authorities:

Manage and approve CAPA phases in accordance with the applicable procedures and regulations.

 

Experience Requirements:

  • Minimum Experience: 2 years of quality assurance in medical device companies.
  • Extensive understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD etc.
  • Previous experience in performing product quality issues and process deviations – high advantage

 

Education:

B.S. Degree in a related scientific or engineering discipline.

 

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.
  • High investigation skill and experience and knowledge of Root Cause Investigation techniques
  • Have the ability to multi-task given projects and timelines.
  • Detail oriented.
  • Knowledge of statistical techniques - preferred

 

Working Relationships: 
Internal:  PD, RA, QA, Ops

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The website was last updated : 14 Feb 2019

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