Root Cause Analysis Specialist

  • eClinicalWorks
  • Westborough, MA, USA
  • Apr 09, 2020
Full time Engineering Health Care Information Technology Pharmaceutical QA-Quality Control

Job Description

As a Root Cause Analyst, you will conduct RCA investigations in order to determine the fundamental cause of the nonconformity that may extend beyond the immediate cause of a failure. You will work along with cross functional teams at eClinicalWorks to continue to deliver safe healthcare technology products to our customers.

Responsibilities

• Lead RCA investigations in order to determine the fundamental cause of the nonconformity that may extend beyond the immediate cause of a failure
• Knowledge of and experience in conformance with ISO13485 and ISO14971/DCB0129 requirements
• Identify and disposition of root cause of issues impacting patient safety and product quality
• Performs data analysis necessary to determine the true root causes of a system, product or process nonconformity.
• Meticulously record steps taken in the root cause investigation and record outcomes into an investigation tracking system.
• Able to communicate technical information, and understand the organizational and regulatory expectations in conducting investigations (RCA/CAPA)
• Work closely and follow through with Regulatory, R&D and Test, to ensure the highest quality products and processes are being developed and deployed as it relates to the root causes identified.
• Build trend reports and communicate findings to team lead and upper management.
• Interface within the CAPA database tool and cross functional department representation to manage CAPA workflow, coordinate CAPA meetings, acquire and report on CAPA KPI’s
• Ensure on time processing and compliance to prevent reoccurrence of non-conformities.
RequirementsRequirements
• Knowledge of and experience in conformance with medical device standards’ s requirements; ISO13485 and ISO14971/DCB0129; which are key for operationalizing CAPA and RCA
• At least 2+ year of RCA work experience.

Preferred
• Master’s degree or equivalent.
• Experience in regulated medical device industry
• Prior experience with RCA and QMS Tools 

Expectations
• Perform other responsibilities as assigned.
• This position is based in our Westborough, MA office.
• May require occasional travel.
• Willing to work additional hours as needed.