The Document Control Specialist supports document changes to finalization and distribution, while assuring compliance to Quality System procedures, through accurate, timely review and processing of documentation change orders based on priority. Ensure all Configuration Management systems are effective and maintain accessiblity for appropriate personnel.
Essential Job Functions:
- Support the Configuration Management process by preparing, reviewing, routing and releasing documents used in fabrication, assembly, and operations, as well as quality system documents.
- Facilitate, communicate and manage changes to released documents with appropriate priority through internal and external customers.
- Analyze change activities to ensure adherence to quality procedures.
- Verify, check and approve revised documents.
- Research and compile change implementation cost estimates.
- Organize and coordinate change implementation plans.
- Track change activity to assure successful and timely change implementation.
- Provide support and training on methods, procedures and requirements for the CM team and site personnel.
- Utilize the Nonin intranet (SharePoint), electronic signature system (Docusign) and ERP system (Dynamics AX and Bluestar) for document processing and storage.
- Utilize BarTender for label template generation and update.
- Maintain and store quality system records in compliance with internal records retention procedures
Required Education & Experience:
- High School Diploma and 3-5 years of Configuration Management/Document Control experience or combination of education and experience
Required Knowledge, Skills & Abilities:
- Good understanding of release, change request and change implementation processes.
- Experience with physical item hierarchies (bill of material).
- General ability to read and understand design documentation.
- Proficient in MS Office Products, MS Access and Adobe Acrobat.
- Ability to interface with individuals at all levels of the company.
- Excellent verbal and written communication skills.
- Understanding of the fundamentals of Configuration Management.
- Associates Degree in technical discipline.
- CMII certificate.
- Solid understanding of Configuration Management best practice principles.
- Working knowledge of operations, inventory management and ERP systems.
- Experience with Bluestar PLM system.
- Experience with Microsoft AX or other ERP system.
- Experience with BarTender label software
- Experience with DocuSign or other electronic signature packages
- Knowledge of medical device regulations (21CFR820, ISO 13485, IEC 62304, ISO 14979, CMDR, JPAL, MDD, 2007/47/EC).
- Sit/stand/walk 8 hrs/day.
- Lift minimum of 20 lbs.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.