Quality/RA Leader - Medical Devices - RDI Global Solutions

 A well rounded quality leader with specific experience in implantable medical device quality systems and regulatory affairs. Will be responsible for leading the quality department of a fast moving medical device organization.

• quality system elements such as document control, corrective action and preventive action (CAPA), non-conforming materials (MRB), supplier corrective actions (SCAR), training, finished goods lot release and components release. 
• microbiological activities such as sterilization and biological testing SOP management, annual testing schedule coordination, testing coordination with microbiology labs, and testing product family management.
• gamma sterilization process activities such as sterilization SOP management, dose audit schedules, test reports, and testing product family management.
• conduct annual internal audit program, audit scheduling, agenda, and reports for 16 elements of the quality system. 
• incoming inspection activities such as supervision of QC Inspectors, review of incoming inspection reports, review of materials certificates, and final component release.
• inspection equipment calibration activities such as managing the internal equipment and external equipment calibration schedule at vendors’ facilities.   Coordinate equipment shipment and calibration with calibration vendors.
• document control activities such as managing change order system, managing the electronic and printed copy “Released Documents” folder, communication of the released MPs, DMRs, labels, routers, etc. with vendors and contract manufacturers. 
• assist in international markets products registrations by obtaining Certificate of Foreign Government (CFG) from the FDA and obtaining apostille on the CFGs from the countries consulate offices in the U.S.
• assist in notified body annual ISO 13485:2003 audits and U.S. FDA inspections.   
• Skills and Certifications Required:Must read, write and understand English. Must be detailed in handling information/data. Knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO. A minimum of a Bachelors degree.  Minimum of 7-10 years experience in a medical device regulated environment.