Manufacturing Engineer
keeping, communication, and documentation practices. Support compliance for GMP, ISO 13485:2016, MDD/MDR, and safety...
keeping, communication, and documentation practices. Support compliance for GMP, ISO 13485:2016, MDD/MDR, and safety...
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...
/MDD Standards. Education: High School Diploma or General Education Degree (GED) with technical or trade school...
documentation (MDD) for both in-house and vendor models. Responsible for model monitoring for DBU fraud models. Develop and review...
under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Ability to detail project...
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...
of ISO, MDD/MDR, GMP/QSR and other applicable regulations Ability to travel up to 25% Preferred Qualifications...
as regulatory requirements per FDA 21 CFR (US), Medical Device Directive (MDD) & Medical Device Regulations (MDR) (EU... and resource negotiation;and ISO 13485, ISO 5840, and ISO 14971 standards and FDA 21 CFR, MDD or MDR (EU), PMDA (Japan), and TPD...
.​ ​​​Ability to assess current Smith & Nephew practices with external standards (GMP’s, ISO 13485, EN, J-GMP, and MDD), guidance...
of calcified plaque. Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Senior Quality...