APN is proud to be a part of Schivo medical. This company fusion allow us to learn and grow. This opportunity is for Schivo medical - NY
Responsibilities
- Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements ;
- Lead quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs ;
- Investigate product quality problems and determine root cause, analyze data, and implement corrective actions ;
- Support product line manufacturing and design stages in accordance with the Validation Master Plan ;
- Work with engineering to develop adequate inspection criteria.
Qualifications
- A minimum of 5 years of quality assurance/engineering experience ;
- Experience with FDA 21 CFR Part 820 Quality System Regulations and ISO Standards (ISO 13485 or AS9000) ;
- Extensive experience in root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) ;
- Experience in a regulated industry (medical device,) is preferred ;
- BS degree in Engineering is preferred.
