QA/RA Documentation Specialist

• 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.

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)