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About the Role
The Quality Clerk supports Quality Assurance and Quality Management System (QMS) activities in a medical device manufacturing environment. This role is crucial for maintaining accurate quality records, supporting document control, assisting with inspections and audits, and ensuring all quality documentation adheres to ISO 13485, company procedures, and regulatory requirements.
Responsibilities
- Maintain and organize quality records, including inspection reports, production records, forms, certificates, and other QMS documentation.
- Perform accurate data entry and maintain quality information in electronic and/or paper-based systems.
- Assist with document control activities, including issuing, filing, tracking, and maintaining controlled documents and forms.
- Review quality records for completeness, accuracy, legibility, and proper approvals.
- Support the processing and tracking of Nonconformances, Corrective and Preventive Actions (CAPA), complaints, deviations, and other quality events.
- Assist Quality personnel with the preparation and maintenance of audit documentation and records.
- Support internal, customer, and regulatory audits by retrieving requested documents and records.
- Maintain inspection and testing documentation and ensure records are properly filed and traceable.
- Assist with incoming, in-process, and final inspection documentation as required.
- Track calibration records, inspection equipment documentation, and other quality-related records.
- Assist in monitoring quality metrics, spreadsheets, and reports.
- Communicate with Production, Engineering, Operations, and Quality personnel regarding missing or incomplete documentation.
- Ensure records are maintained in accordance with company retention requirements and applicable ISO 13485 requirements.
- Follow established procedures for document changes, record corrections, and data integrity.
- Maintain confidentiality and protect sensitive company, customer, and product information.
- Perform other quality and administrative duties as assigned.
- Follow the organization's Quality Management System and applicable procedures and work instructions.
- Support compliance with ISO 13485 requirements related to documented information and quality records.
- Maintain accurate and traceable quality documentation.
- Support audit readiness by ensuring required records are complete, current, and readily retrievable.
- Report documentation discrepancies, errors, or potential quality issues to appropriate Quality personnel.
- Participate in continuous improvement activities related to quality processes and documentation.
Requirements
- Strong attention to detail and accuracy.
- Excellent organizational and record-keeping skills.
- Basic to intermediate computer skills, including Microsoft Word and Excel.
- Ability to maintain accurate records and handle confidential information.
- Ability to follow written procedures and work instructions consistently.
- Strong communication and interpersonal skills.
- Ability to work independently and prioritize multiple tasks in a fast-paced environment.
Skills
- Attention to detail
- Accuracy and data integrity
- Organization and time management
- Documentation and record control
- Teamwork and communication
- Problem-solving
- Confidentiality and professionalism
- Commitment to quality and regulatory compliance
- Microsoft Word
- Microsoft Excel
Experience Level
- Experience in quality, manufacturing, medical devices, regulated industries, or document control preferred.
- Familiarity with ISO 13485 and Quality Management Systems is preferred.
Education Level
- High school diploma or equivalent required
- Associate degree or relevant technical education preferred