Job Description

We are seeking an experienced detail-oriented Quality Administrator to support the maintenance, continuous improvement, and effective implementation of our Quality Management System (QMS) based on ISO 9001:2015 standards. The Quality Administrator will play a vital role in ensuring our QMS documentation is accurate, up-to-date, and effectively utilized across the organization. The ideal candidate must be proactive; highly organized with excellent administrative; communication skills; interpersonal skills, and a solid knowledge of quality management principles, particularly ISO 9001:2015.

Requirements

Document Control:

Manage and maintain the organization's document control system in accordance with ISO 9001:2015 requirements. Oversee the creation, review, approval, distribution, revision, and obsolescence of controlled documents (e.g., policies, procedures, work instructions, forms, records). Maintain accurate and comprehensive document registers and logs, both electronic and physical (if applicable). Ensure all personnel have timely and appropriate access to the latest approved versions of relevant documents.

Record Management:

Implement and manage effective systems for the identification, storage, protection, retrieval, retention, and disposal of quality records as required by ISO 9001:2015. Organize and maintain efficient record-keeping systems, ensuring ease of access and retrieval. Ensure records are readily available and prepared for audits and management reviews.

Internal Audit Support:

Actively participate and assist in the planning, scheduling, and coordination of internal audits as per the audit program. Develop audit documentation, including audit checklists and reports (under guidance and potentially independently, depending on experience). Track corrective actions, proactively follow-up on completion, and assess the effectiveness of corrective actions resulting from internal audits. Maintain comprehensive audit records and reports, providing summaries and trend analysis as required.

Corrective and Preventive Action (CAPA) Management:

Manage and support the CAPA process, including logging, tracking, and proactively following up on corrective and preventive actions. Maintain a robust CAPA log, ensuring timely completion of actions and escalating overdue items as necessary. Assist in the analysis of CAPA data, identify trends, and contribute to reporting on CAPA effectiveness.

Management Review Support:

Proactively assist in the preparation of data, reports, and presentations for Management Review meetings. Compile, organize, and distribute Management Review documentation in a timely manner. Maintain comprehensive records of Management Review meetings, track action items, and follow-up on completion.

Training and Awareness:

Maintain detailed training records related to the QMS and quality procedures, ensuring accuracy and completeness. Assist in the coordination, scheduling, and potentially delivery of quality-related training sessions. Develop and support initiatives to actively promote quality awareness and a quality culture throughout the organization.

Communication and Coordination:

Serve as a primary point of contact for quality-related administrative inquiries, providing prompt and helpful responses. Effectively communicate quality-related information to relevant personnel across departments as directed, ensuring clarity and understanding. Liaise with various departments to gather information, facilitate compliance with QMS requirements, and build collaborative relationships.

QMS Maintenance and Improvement:

Actively contribute to the maintenance, review, and improvement of the QMS documentation, suggesting updates and enhancements. Proactively identify areas for process improvement within the QMS and propose practical solutions. Support the implementation of changes to the QMS, ensuring smooth transitions and effective communication.

External Audit Support:

Play a key role in the preparation for and support during external audits (e.g., ISO 9001 certification and surveillance audits). Gather, organize, and present documentation requested by external auditors in a timely and efficient manner. Assist in addressing findings from external audits, contributing to the development of corrective actions and follow-up.

Data Entry and Reporting:

Accurately and efficiently input data into quality management systems or databases, ensuring data integrity. Generate reports and summaries related to quality data (e.g., document status, audit schedules, CAPA status, training compliance), providing insights and trends.

General Administrative Support:

Provide comprehensive general administrative support to the Quality team, including managing calendars, scheduling meetings, preparing presentations, managing correspondence, and handling confidential information. Maintain office supplies and equipment related to quality administration, ensuring efficient operation of the quality department.

Desired Skills & Qualifications

Education:

Undergraduate degree required. Preferred fields of study include Business Administration, Quality Management, or related discipline.

Experience:

3-5 years of proven work experience in a Quality Administration role or similar function within a Quality Management System environment is essential. Direct experience working with ISO 9001:2015 standards is highly desirable. Demonstrable experience with document control and electronic record management systems is a significant advantage.

Skills:

Exceptional organizational and time management skills: Proven ability to manage multiple tasks, prioritize effectively, and meet deadlines in a fast-paced environment. Meticulous attention to detail and accuracy: Critical for document control, record keeping, and data management within a QMS. Advanced proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook. Experience with database software, QMS software (e.g., document management systems, audit management tools), or ERP systems with quality modules is highly beneficial. Excellent written and verbal communication and interpersonal skills. Strong problem-solving skills. Team player with strong collaboration skills. Proactive and highly self-motivated. Solid understanding of quality management principles and ISO 9001:2015 requirements. Commitment to confidentiality and ethical conduct. Reliable, dependable, and highly responsible Positive, proactive, and solution-oriented attitude Strong commitment to accuracy, quality, and continuous improvement * Demonstrates initiative and a willingness to learn and adapt to evolving requirements