Quality Assurance Specialist, Medical Device

Cayenne Medical Inc. is a fast growing medical device-orthopedic company located in Scottsdale, Arizona.  Cayenne Medical is currently looking for a Quality Assurance Specialist with 5-8 years experience in a medical device or pharmaceutical industry.   College education is preferred.  Knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO is required. 

Job Responsibilities:

Lead document control activities such as managing change order system, managing documents and records filing.  Implement a new PLM (Product Lifecycle Management) system, validate, and train the team.  Assist engineering team with release and documentation of drawings.  Manage complaints system and CAPA system.  Assist in conducting complaint investigations. Lead employee training program.  Participate and provide input to training on department/division procedures, and policies. Lead internal audits. Prepare and present project updates.  Ability to create, review and coordinate corrective action and preventive action (CAPA) activities. Assist in investigating discrepancies and following up on corrective and preventive actions and monitor post-implementation effectiveness.   Assist in incoming inspection activities. Assist in MRB activities and lot disposition.  Provide QA support to pilot production facility. Perform reviews of device history records (DHRs), written procedures, change control, deviation reports, test records and other documentation for compliance to GMPs; Other duties as assigned.  Provide positive example and actively promotes compliance to all standards. Maintain a professional working relationship with internal and external customers and support staff.