The Quality Assurance (QA) Manager will oversee the activities of the quality assurance department and staff. QA manager is responsible for developing, implementing, and maintaining Quality Management systems standards to ISO-13485 and reliability testing for the organization's products and/or development processes.
First Name
Last name
E-mail
Telephone
Job sought
Resume
Upload your resume
Additional information about you
Description
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 ;
#J-18808-Ljbffr