QA Admin

The Quality Assurance Administrator supports and sustains CIVCO’s Quality Management System (QMS) by administering, coordinating, and maintaining quality processes, records, and data essential to regulatory compliance and operational effectiveness. This role serves as a central point of coordination for quality system activities, including document control, nonconformance management, complaints, corrective and preventive actions (CAPA), deviations, audits, and quality reporting.

The position ensures timely, accurate flow of quality records such as DHRs, change notices, SOPs, and investigation documentation, and supports cross-functional communication related to quality issues, customer complaints, and material review activities. Working under the direction of Quality leadership, the Quality Assurance Administrator executes established quality processes in compliance with FDA cGMP, ISO 13485, MDSAP, other global regulatory requirements and internal requirements, contributing to the consistent manufacture of safe, effective, and compliant medical devices.

(Other duties may be assigned)

• Quality Systems:
• Document and execute the CIVCO Quality Systems processes to ensure compliance with company, customer, FDA/cGMP, ISO 13485, MDSAP, and other global regulatory requirements.
• With direction, execute Document Control responsibilities including Document Disposition, CN Disposition, quality record filing/ retrieving.
• With supervision maintain Quality Systems documentation and coordinate/perform activities as applicable for customer & supplier non-conformance/quality issues using the timeframe required by the Quality System.
• Maintain the Corrective/Preventive Action (CAPA), Complaint on Material (CEM) and Non-Conforming Material (NCM) systems and maintain applicable records and databases.
• Maintain Quality Plan and Summary Report Log to ensure on-time completion as defined in CIVCO’s Quality Management System.
• With direction maintain Deviation system and documentation as required by CIVCO QMS.
• With direction, develop and communicate internal audit schedule and assist in maintenance of the internal audit program as needed.
• With direction, author and manage change management workflows within CIVCO QMS.
• Additional Quality Activities/Operations Support as needed:
  • Gather information and documentation for non-conforming materials and lead Material Review Board meetings.
  • With direction, compile the data and generate schedule for post-production risk management review meetings.
  • With direction, maintain Product Hold Order system and documentation as required by CIVCO QMS.
  • With direction prepare and distribute reports and trend analyses of corrective actions, preventative actions, and COM’s relating to suppliers, customers, internal quality systems and management review.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Minimum high school diploma or General Education Degree (GED). Prefer an Associate’s degree (AA) in a related field; one to three years of quality related experience in an FDA/GMP manufacturing environment required, or equivalent combination of education and/or experience. Office skills such as word processing, spreadsheet, and database skills required.

• Excellent written and verbal communications skills.
• Demonstrates interpersonal and self-management skills.
• Strong organizational skills and attention to detail.
• Experience with Microsoft Office applications including Excel, Word, Power Point and Outlook.
• Prefer experience in a regulated environment such as ISO 13485.
• Prefer internal quality auditor or lead auditor certification in a regulated environment.
• Prefer experience with Enterprise Resource Planning (ERP) systems

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential…