Coordinator.Quality Assurance

Job Details:

Job Location:

Elyria, OH 44035, Position Type:
Full Time,

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.

• 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