Medical Device Document Control Specialist -- SAHDC5833647

Medical Device Document Control Specialist -- SAHDC5833647 at Compunnel Inc. Medical Device Document Control Specialist -- SAHDC5833647 at Compunnel Inc. in Victoria, Minnesota Posted in 3 days ago.

Type:

full-time

Job Description:

Meticulous attention to detail and strong organizational skills. Skilled at prioritizing in a demanding and fast paced environment while producing error free work and meeting required deadlines. Adept at multitasking and troubleshooting while appropriately addressing issues as they arise.

Essential Duties, Critical Success Factors, Responsibilities, Authorities and Required Interactions:

Job Responsibilities:

• Implement changes based on red-lines and format engineering documents per documentation standards
• Ensure guidelines and definitions are consistently applied across templates and documents.
• Review all documentation for accuracy, completeness and consistency in content, format, files and authorizations.
• Filing, scanning, copying and electronic notification and distribution of released documentation.
• Store and control archived documentation. Success Factors
• Meticulous attention to detail and strong organizational skills.
• Skilled at prioritizing in a demanding and fast paced environment while producing error free work and meeting required deadlines.
• Adept at multitasking and troubleshooting while appropriately addressing issues as they arise.
• Ability to work independently.
• Well versed in good documentation practices
• Team Player - Thrives in a team environment to achieve a shared goal or outcome Education and/or

Work Experience Requirements:

• 2-3 years of relevant experience
• Graduate from a recognized program in QA preferred
• Previous QA and QMS experience
• Previous experience working within a GMP manufacturing environment would be an asset.
• Experience working with Electronic Document Management System.
• Knowledge of

ISO 9001

standard required; knowledge of

ISO 13485

is an advantage

• Prior experience with documentation of Life Science or Medical Device products.
• Strong word processing skills using Microsoft Office products including application and editing of Word multilevel lists, pagination, headers/footers, tables and track changes.
• Strong communication skills, both written and verbal.
• Experience with design document engineering change orders.
• Knowledge of document control procedures including database storage, maintenance, and revision control