Description
Job Description:
· Responsible for assisting in the development, implementation and maintenance of the DNI quality system and document control. This position can encompass multiple functional areas within the Quality group.
· Maintain all DNI policies, processes, procedures and controls to ensure that all proper objective evidence is documented.
· Participate in the maintenance of the DNI Quality System to ensure compliance to Quality System Regulations, ISO 13485, and Healthcare Corporate Policies.
· Make updates as necessary to Quality System procedures when updates and revisions occur to Quality System Regulations, ISO 13485, and Healthcare Corporate Policies.
· Create and maintain Master Files for DNI controlled documents to ensure document history and current revisions of system procedures, work instructions, forms, quality acceptance criteria’s and other quality documents.
· Publish all controlled documents as required.
· Conduct and coordinate routine maintenance for updating or creating documents.
· Support the Swinnea Document Services Group in maintaining all external controlled documents.
· Maintaining the document change control process and managing the Master Document List.
Required Skills/Experience:
· Minimum 2 to 4 years quality assurance experience in a GMP environment
· Working knowledge of Quality System Regulation (QSR 21 CFR 820) and ISO 13485:2003
· Ability to accurately copy, sort, and file documents.
· Ability to comprehend written and oral communications, to work with others and function as part of a team, and to function in a minimal supervision environment.
· Good computer skills to include proficiency in word processing, spreadsheets, and database activities.
· Good oral communication skills.
· Prior experience in a medical manufacturing environment is highly preferred.
· Experience in quality assurance and/or regulatory compliance in a medical institution or industry setting is highly preferred.
· Proficiency with Microsoft Office applications (Outlook, Word, Excel, Access, PowerPoint)
Education: Undergraduate Degree
