Manufacturing Engineer II
, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA...
, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA...
and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP...
Requirement Document BRD Functional Requirement Document FRD Minor Development Document MDD Jira Epics etc. · Facilitate project...
Requirement Document BRD Functional Requirement Document FRD Minor Development Document MDD Jira Epics etc. · Facilitate project...
ISO 10993 Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD...
, MDR/MDD and other applicable global regulatory requirements and standards. Apply balance of risk, regulatory intent... of experience in design quality. Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Quality standards...
Council Directive: 93/42/EEC Medical Devices Directive (MDD) EU Regulation: 2017/745 Medical Devices Regulation (MDR) MDSAP...
(including QSR, ISO, OSHA, IVDD, MDD) are met and the inspection schedule is satisfactorily attained. Analyzes work processes... - Strong leadership and organizational skills - Knowledge of current QSR, ISO, OSHA, IVDD, MDD regulations desirable...
and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE. 4. Ability to execute established procedures and protocols... such as FDA QSR, ISO 13485, and the MDD required. Experience in a start-up environment preferred. Experience with catheter-based...
and other health authorities (Highly preferred) Be knowledgeable of US cGMP regulations, industry best practices, EU MDD, and ISO...