Description
This position will be responsible for working with the Associate Director of Quality to maintain an ISO13485 & 21CFR Part820 compliant Quality System for the Company. Emphasis will be placed on:* Manage MasterControl system and configuration for documentation and training modules
* Maintain DHFs in compliance to established procedures;
* Execute trend analysis on Quality Systems for input into established Management Review procedure;
* Assist in investigations and CAPA (leading root cause analysis & writing documentation);
* Write software validation documentation;
* Responsible for ensuring internal / external Quality System Requirements are adhered to throughout product and process lifecycles.
* Reporting on all of the above listed functionality
Requirements
1. Author documents for the Quality System including procedures, forms, and templates. Assist with review, editing, and implementation of Quality System documents.
2. Manage Master Control System documentation and training modules.
a. Create Master Control user documents.
b. Review documents for completeness, consistency, content, and format prior to uploading and routing in MasterControl.
4. File, maintain and audit Design History documentation.
5. Develops and executes (as required) training on GxP and annual Quality System training.
6. Conducts internal and supplier audits as lead. Writes audit plans, audit reports, and associated non-conformances and CAPAs. Performs and leads root cause analysis with input from subject matter expert.
7. Lead root cause investigations and documentation for non-conformities. Reviews non-conformities for compliance and presence of objective evidence.
8. Creating and writing the following technical documents associated with the validation and implementation of a CRM (Customer Relationship Management system), an Inventory Management system, and an upgraded Document Management system: Requirements Specification, Risk Analysis, Verification / Validation Plan, Verification / Validation Protocol, Validation Report, & Traceability Matrix.
12. Possess in-depth knowledgeable of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDD, ISO 13485.
To find out more about Real please visit www.realstaffing.com