Coordinator.Quality Assurance

Job Details: Job Location: Taylor Street - Elyria, OH, Position Type: Full Time, Salary Range: Undisclosed, Job Shift: Day, Essential Functions: Coordinate and maintain employee training requirements in accordance with the Quality Management System (QMS). Assign required training based on employee roles, applicable procedures, work instructions, and regulatory requirements. Monitor training completion and follow up on overdue or incomplete training. Maintain accurate and controlled employee training records and documentation. Support the development, revision, and issuance of training materials, including procedures, work instructions, and quality-related communications. Coordinate training activities associated with new or revised procedures, work instructions, and QMS documents. Prepare training status reports, metrics, and other information for Quality Management review. Support internal, customer, and regulatory audits by providing training records and other required documentation. Coordinate and maintain the Quality Hold process for products, components, materials, or processes identified as potentially nonconforming. Ensure Quality Holds are properly documented, identified, communicated, and controlled in accordance with established procedures. Maintain the Quality Hold log and monitor the status and aging of open Quality Holds. Ensure Quality Hold records are complete and properly closed following the approved disposition and completion of required actions. Coordinate the initiation, review, approval, implementation, monitoring, and closure of Temporary Protocols in accordance with established procedures. Maintain accurate records of Temporary Protocols, including effective dates, expiration dates, approvals, and required follow-up actions. Ensure Temporary Protocol documentation is complete, controlled, and readily available for audit and regulatory review. Comply with Good Documentation Practices (GDP) and ensure quality records are accurate, legible, complete, and traceable. Adhere to all applicable safety policies and procedures and contribute to the achievement of departmental and organizational safety goals and objectives. Identify opportunities for continuous improvement and actively participate in the implementation of approved improvement initiatives. Effectively manage time, energy, and available resources to meet established priorities and departmental goals. Maintain a clean and organized work environment in accordance with 5S principles. Complete all required training applicable to the assigned position and maintain required qualifications. Demonstrate a positive, flexible, and collaborative approach and a willingness to take on additional responsibilities as requested or required.Qualifications: Associate degree or equivalent 2+ years of experience in Quality, manufacturing, medical devices, or a regulated industry preferred. Proficiency with Microsoft Office, particularly Excel and Word. Effective communication skills Ability to work under minimal supervision Must have thorough understanding of quality systems and their relationship to job performance including ISO Overview, corrective/preventative actions and work instructions Ability to manage multiple activities, deadlines, and priorities.An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet