CAPA Engineer
Description
As a CAPA Engineer, you will conduct and lead root cause analysis (RCA) investigations in order to determine the fundamental cause of a nonconformity that may extend beyond the immediate cause of a failure. You will work along with cross functional teams at eClinicalWorks to develop and implement corrective and preventative actions (CAPAs) that flow from the identification of root causes in order to continue to deliver safe healthcare technology products to customers.
Responsibilities
- Ability to conduct “Blameless PostMortems” assessments of technical failures with appropriate teams and define remediation plans to avoid the same error in the future.
- Lead RCA investigations as a software engineer or software architect in order to determine the fundamental cause of a 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
- Perform 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.
- Communicate technical information and understand the organizational and regulatory expectations in conducting investigations
- Manage development of CAPAs, including identification of CAPAs, documentation of CAPAs, CAPA workflow, coordination of CAPA meetings, and reporting on the same
- Work closely and follow through with Regulatory, Development, Software Architecture and Quality Assurance Testing 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 upper management
- Ensure on time processing and compliance to prevent re-occurrence of non-conformities.
Requirements
- 5 years of experience in Software Engineering or Architecture Background.
- 5 years of experience in conformance with medical device standards requirements; ISO13485 and ISO14971/DCB0129; which are key for operationalizing RCA and CAPA
- At least 2+ year of RCA and CAPA work experience as a software engineer or architect
Preferred
- Master’s degree or equivalent
- Experience in regulated medical device industry
- Prior experience with RCA and QMS Tools
- Prior Software experience
Expectations
- Perform other responsibilities as assigned
- This position is based in our Westborough, MA office
- Willing to work additional hours as needed