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Job description
Quality ClerkThe Quality Clerk supports the Quality Assurance and Quality Management System (QMS) activities within a medical device manufacturing environment. This position is responsible for maintaining accurate quality records, supporting document and data control, assisting with inspections and audits, and ensuring quality documentation is complete, accurate, and maintained in accordance with ISO 13485, company procedures, and applicable regulatory requirements.Responsibilities include maintaining and organizing quality records, performing accurate data entry, assisting with document control activities, reviewing quality records for completeness, accuracy, legibility, and proper approvals, supporting the processing and tracking of Nonconformances, Corrective and Preventive Actions (CAPA), complaints, deviations, and other quality events, assisting Quality personnel with the preparation and maintenance of audit documentation and records, supporting internal, customer, and regulatory audits by retrieving requested documents and records, maintaining inspection and testing documentation, assisting with incoming, in-process, and final inspection documentation, tracking calibration records, inspection equipment documentation, and other quality-related records, assisting in monitoring quality metrics, spreadsheets, and reports, communicating with Production, Engineering, Operations, and Quality personnel regarding missing or incomplete documentation, ensuring records are maintained in accordance with company retention requirements and applicable ISO 13485 requirements, following established procedures for document changes, record corrections, and data integrity, maintaining confidentiality and protecting sensitive company, customer, and product information, performing other quality and administrative duties as assigned, following the organization's Quality Management System and applicable procedures and work instructions, supporting compliance with ISO 13485 requirements related to documented information and quality records, maintaining accurate and traceable quality documentation, supporting audit readiness by ensuring required records are complete, current, and readily retrievable, reporting documentation discrepancies, errors, or potential quality issues to appropriate Quality personnel, and participating in continuous improvement activities related to quality processes and documentation.Education: High school diploma or equivalent required; associate degree or relevant technical education preferred.Experience: Experience in quality, manufacturing, medical devices, regulated industries, or document control preferred. Familiarity with ISO 13485 and Quality Management Systems is preferred. 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.Key Competencies: 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.
Worksite address
albany, NY, 12204, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.