Medical Device Documentation Specialist
Planet Pharma, Eagan, MN, United States
The Documentation Coordinator I will be responsible for maintaining the document control process, which includes making document changes, routing for review and approval, making documents effective, distributing documents and making notifications. In addition, the Documentation Coordinator I will be responsible for maintaining the training process, which includes keeping the training matrix current, routing training assignments, ensuring training has been completed and filing training records.
PREFERRED SKILLS & ABILITIES
Document control and medical device industry a plus
Ability to understand FDA 21 CFR Regulations, Good Documentation Practices, ISO 13485, MDSAP
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
Follow all procedures and work instructions defined in the Quality System Manual
Review of document change orders to confirm all steps have been completed
Process, implement and release document change orders
Distribute controlled documents and remove obsolete revisions
Coordinate training of revised documents
Update technical files with document changes
Create and/or update specifications, procedures, work instructions, forms and labels using Word and Excel in support of changes
Support inspections and audits performed by FDA, Notified Body and customers
Assists in compiling Design History Files
Support agency listings and certifications: FDA, ISO 13485, MDSAP
Support quality inspection department as needed
Support manufacturing to keep product documentation accurate and up to date
Support purchasing with complete documentation as required
Support quality functions as needed
Perform other duties as assigned by manager or supervisor
EDUCATION & EXPERIENCE REQUIREMENT
Must have proven attention to details and excellent organization skills
Two-year degree or equivalent experience; ability to apply learned technology to Company products and processes
Intermediate proficiency with Microsoft Word & Excel, Adobe Acrobat, LabelView
Must possess excellent verbal and written communication skills in English, which includes the ability to read, write and speak to comprehend and execute internal procedures, drawings and Manufacturing Work Instructions (MWI’s)
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PREFERRED SKILLS & ABILITIES
Document control and medical device industry a plus
Ability to understand FDA 21 CFR Regulations, Good Documentation Practices, ISO 13485, MDSAP
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
Follow all procedures and work instructions defined in the Quality System Manual
Review of document change orders to confirm all steps have been completed
Process, implement and release document change orders
Distribute controlled documents and remove obsolete revisions
Coordinate training of revised documents
Update technical files with document changes
Create and/or update specifications, procedures, work instructions, forms and labels using Word and Excel in support of changes
Support inspections and audits performed by FDA, Notified Body and customers
Assists in compiling Design History Files
Support agency listings and certifications: FDA, ISO 13485, MDSAP
Support quality inspection department as needed
Support manufacturing to keep product documentation accurate and up to date
Support purchasing with complete documentation as required
Support quality functions as needed
Perform other duties as assigned by manager or supervisor
EDUCATION & EXPERIENCE REQUIREMENT
Must have proven attention to details and excellent organization skills
Two-year degree or equivalent experience; ability to apply learned technology to Company products and processes
Intermediate proficiency with Microsoft Word & Excel, Adobe Acrobat, LabelView
Must possess excellent verbal and written communication skills in English, which includes the ability to read, write and speak to comprehend and execute internal procedures, drawings and Manufacturing Work Instructions (MWI’s)
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