Job Description:- 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 indicatorsSupport data collection and analysis for reporting on key performance indicatorsSupport 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 skillsQA process skills
Computer knowledge and skill
PreferredBA or BS degree in quality, engineering, or IT/Software discipline
Experience with quality quality processes and tools
Knowledge of safety requirements and legal standardseQMS skills
Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745 Quality Specialist (ASQ or similar Certifications)
