Veterans Preferred - Recall Coordinator-

Company: MODIS
Location: Irvine
Posted on: April 8, 2021

Job Description:

Military Veterans are Encouraged to Apply. Contract Position: QA Recall Coordinator 1 yr contract with possibility of hire after. Bachelor--------s degree required. A QA/RA background is a must as well as experience coordinating product recalls.. Recall coordination Experience with documentation for conducting recall of medical devices Understanding of FDA regulations around recalls Organize documentation into presentable manner Project Management Coordinate cross-functional collaboration: Internal and External Service teams Technical Support Product Managers Supply Chain Quality Tracking of key metrics around product recall POSITION This position supports product recall efforts with coordination of team members and maintaining documentation related to the recall. ESSENTIAL FUNCTIONS AND BASIC DUTIES Schedule and coordinate regular update meetings with cross-functional team Maintaining meeting minutes Coordinating and following up on action items for recalls Updating documentation from team and following up on action items Building recall binder Gathering customer responses Tracking completion of product replacements Organizing the objective evidence for audit preparation Prepare monthly update reports to FDA per requirements. QUALIFICATIONS Bachelor--------s degree, and preferably medical device or pharmaceutical Regulatory Affairs or Quality Assurance experience Required Knowledge: Understanding of FDA recall requirements (21 CFR 806) and guidance Experience Required: Previous experience with coordination of medical device or pharmaceutical recalls or field actions. Skills/Abilities: Good communication skills (written and verbal) Strong excel spread sheet and formulas Book keeping and attention to details WORKING CONDITIONS TRAVEL: Position may be mostly remote with requirement to be in office towards end of project. SPEAKING: English PHYSICAL: Computer work Required Hours: The regular hours for this position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless otherwise stated by the department manage Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please The Company will consider qualified applicants with arrest and conviction records

Keywords: MODIS, Irvine , Veterans Preferred - Recall Coordinator-, Other , Irvine, California