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