Veterans Preferred - Recall Coordinator-
Company: MODIS
Location: Irvine
Posted on: April 8, 2021
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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
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