- The Document and Data Control Specialist is responsible for performing the review, processing, and release of quality management system documentation and engineering project documentation.
- Documentation will be provided by different organizations which will be evaluated for compliance to the systems. A Good Documentation review will be performed to complete the evaluation
- The documents will be processed through a system of scanned records which are stored in system designated locations to support the QMS, DHF, or DMR.
Key Duties and Responsibilities:
- Manage, store, and track company documents for both the Quality Management System and engineering projects.
- Responsibility for validation and revalidation activities for the documentation software systems.
- Administer the PLM or eQMS system and DocuSign systems as they evolve and change.
- Administer all users and control levels of the software.
- Ensure all controlled documents follow the correct routing guidelines.
- Ensure all documents are routed and approved within the appropriate timeframe.
- Perform all training for eQMS or PLM systems and activities.
- Monitor document lifecycles to ensure appropriate and necessary reviews are conducted.
- Ensure documents are regularly reviewed based on system guidelines.
- Assist in preparing, providing, and/or retrieving documents as needed for internal or external audits.
- Track, trend, and report status of deviations and change orders as needed.
- Issue and track controlled copies of documents for the system and supporting production.
- Communication of all changes and releases of the QMS to the company.
Training and Skills:
- Minimum 3 years of industry related experience with high-level use of a PLM or eQMS including experience of software implementation in a regulated industry.
- Excellent technical writing skills
- Must be proficient in using Microsoft Word and Excel. Specialist should be proficient with computers to support proper records storage and archiving.
Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work Location: USA Morrisville, NC – onsite
Reports to: Director, Quality Management Systems
Authorized to work in the US