Location: St Paul MN
Duration: 12 months extendable
Plan, develop, organize and write clear and concise policies and procedures.
Understand the applicable standards to assure procedures are in compliance with those standards.(e.g., 21 CFR 820, ISO 13485:2016, ISO 9001:2015, etc.)
Work with employees at all levels to learn the processes and define the needs to assure procedures are workable.(this includes working with remote associates from other businesses)
Produce electronic documentation in addition to hard copies.
Analyze documents to maintain continuity of style of content
Manage updates and revisions to documents
Utilize electronic document management systems to revise quality system documents and circulate them for approvals
Experience working in a regulated environment, preferably medical device.