looking for in a Director Associate Director Quality Assurance To excel as the Associate Director of Quality Assurance at RevaMedicalLLC...Join RevaMedical as our Full-Time Director or Associate Director of Quality Assurance and take a pivotal role in the...
of requirements (commercial, Regulatory, cGMP, GDP, GLP, ISO-, etc.) specific for REVA processes and products and adapt to the quality... in chemistry is required. Minimum of 10 years related Quality Control experience in a drug, medical device, or similarly regulated...
, risk management, CMC etc. Can be trusted by REVA management as an independent regulatory expert on strategy and issue... Management. Following REVA Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP...
and reporting of organizational quality metrics. This position is responsible for the development and maintenance of the REVA...
, Corrective and Preventive Actions (CAPA), and electronic batch records (EBR) within the medical device manufacturing process...
the procedures and instructions in the REVAMedical Quality System in the execution of all relevant tasks... or science. MS or advanced degree desirable. A minimum of 4 plus years' experience in Medical Device or Pharmaceutical Quality...
room environment Experience in an ISO and/or medical device manufacturing or similarly regulated environment...