Quality Engineer I, Post Market Surveillance (PMS)
requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies...
requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies...
and exportability. · Execute comprehensive reviews of key acquisition milestones, including Materiel Development Decisions (MDD...
of regulatory compliance Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations...
supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR...
), ISO13485, European Union Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well..., EU’s MDD, Canadian Regulations) is required. Proficiency in the Microsoft Office suite of products is required. American...
, ISO, MDD) & J&J policy & procedure requirements. Bachelor's degree in the field of computer science, engineering...
(International Organization for Standardization), MDD (Medical Devices Directive) is preferred. Knowledge of Standard...
and experience of FDA 21 CFR Part 820, and 510(k) submission requirements;Knowledge of Canadian Medical Device Regulations, MDD...
Organization for Standardization), MDD (Medical Devices Directive) is preferred. Knowledge of Standard manufacturing performance...
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...