**Manufacturing Documentation Specialist** -

+ Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency and Corrective and Preventive Actions (CAPAs)
+ Explain scientific and technical ideas by authoring clear and concise QMS documents, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
+ Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
+ Assist in internal and external ISO 13485 audits of QMS
+ Monitor governmental and associated industry organizations’ standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)

This is an onsite role, based in Corona California with the general work hours of Monday – Friday, 8 am – 5pm.

Additional Responsibili...