Job Description
Job DescriptionDescription:
- Owner of document control functions of change control by ensuring that records are readily available, properly defined, categorized, maintained, and implemented according to the document type.
- Scanning files and dictating the organization of the file structure to establish a consistent place for the organization to pull records and procedures from. Support the shift to a paper-less system for record control.
- Supporting regulatory with creating templates and providing relevant product documentation for submissions and registrations
- Support the documentation and tracking of Nonconforming materials, dispositions and closures.
- Training document coordination and management. Building tools (electronic and paper) to drive training capture, performance and materials for departments to utilize
- Software Validation process ownership.Intake, recording, assisting software owners with validation expectations per the SOPs in place
- Guide QMS sustaining activities through active completion of Standard Operation Procedure and Work Instruction expectations.
- Coordinate the reporting/analysis of quality data and resolution of material and product quality issues
- Improve process quality by making recommendations for change while working with relevant teams and departments to improve processes
- Drive continuous improvements in all areas, focusing on key performance indicators
- Support data collection and analysis for reporting on key performance indicators
- Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements
- Conduct internal audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.
Requirements:
Required
- 0-3 years’ experience in regulated industry
- Experience with scanning, sorting and creating organized filing structures
- Experience with MS Word, Excel, Powerpoint, Access and Adobe softwares
- Excellent written and verbal communication skills.
- Excellent organizational skills and detail oriented
- Legally authorized to work in the United States.
- Organization
- Strong written and verbal skills
- Collaboration skills
- QA process skills
- Computer knowledge and skill
Preferred
- BA or BS degree in quality, engineering, or IT/Software discipline
- Experience with quality quality processes and tools
- Knowledge of safety requirements and legal standards
- eQMS skills
- Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745
- Quality Specialist (ASQ or similar Certifications)