Quality Assurance Specialist
to site, division, corporate, FDA, ISO, MDD, MDR and individual country requirements. Driving good manufacturing...
to site, division, corporate, FDA, ISO, MDD, MDR and individual country requirements. Driving good manufacturing...
International Standard, CMDCAS, FDA, and MDD/MDR regulations. We operate the Quality System as an overall management system...
. PNSCR conducts phase II-IV psychiatry trials ranging from MDD, Schizophrenia, Alzheimer's Disease, and Bipolar Disorder...
, ISO 14971, IEC 60601-1, IEC 60601-2-18, FDA and MDD. Experience developing embedded systems with optics for medical...
/211;ISO 13485, ISO 14971, CMDR, MDD and JPAL is preferred. Solid grasp of computer systems used in a manufacturing...
in review and compilation of the submission files to obtain market approvals in the USA (510(k), Canada, Europe (MDD/MDR...
and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab Ability to work...
and equipment Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards Participate in FDA...
with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA...
with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA...