Purpose

This position is responsible for providing Quality Engineering support in the design, development, manufacture and post-market medical device activities.

Responsibilities

· Assist in performing validation activities for processes, facilities, manufacturing, and test equipment in compliance with domestic and international regulations

· Support quality assurance activities, including, but not limited to: NCMRs and CAPAs

· Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause

· Assist in the resolution of quality issues related to non-conformance reports, Customer Complaints and CAPAs

· Provide Quality support to production and engineering

· Failure Analysis - Provide quality engineering support to analyze returned product

· Understands root cause investigation process and able to initiate routine problem-solving investigations

· Assist in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations

- Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions

- Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)

· Collaborate with Operations on process improvement projects

· Investigate customer complaints and document investigation findings

· Perform inspection of incoming components, materials and products

 

Education

· 4-year degree in an Engineering or Science discipline

Experience

· 2 years minimum experience in a medical device environment

Knowledge and Training

· Working knowledge of specifications, work instructions, standard operating procedures, regulations, and standards

· Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel