Quality Systems Associate

Quality Systems Associate

Reports to: Quality Control Manager

Non-Exempt | Shift: Monday - Friday, 1st shift 

Position Summary

The Quality Systems Associate is responsible for ensuring the accuracy, completeness, and compliance of manufacturing documentation through comprehensive router auditing activities. This role requires a strong understanding of medical device manufacturing processes, quality system requirements, Good Documentation Practices (GDP), and regulatory compliance standards. The position involves reviewing production records, verifying traceability and documentation accuracy, identifying discrepancies, and supporting continuous improvement initiatives within the Quality Management System (QMS). This position plays a critical role in helping EXALTA Group maximize the number of patients served while maintaining the highest standards of product quality, safety, and regulatory compliance.

Responsibilities

• Perform detailed audits of manufacturing routers, travelers, Device History Records (DHRs), and associated production documentation to ensure completeness, accuracy, and compliance.
• Verify that all manufacturing and inspection operations have been completed and documented according to approved procedures and specifications.
• Review production records for proper signatures, dates, revision levels, material traceability, lot control, and compliance with Good Documentation Practices (GDP).
• Identify documentation discrepancies, missing information, and nonconformances, and coordinate timely resolution with Manufacturing, Quality, and Engineering teams.
• Ensure compliance with applicable FDA regulations, ISO 13485 requirements, internal quality procedures, and company policies.
• Support lot release activities through completion of final router audits and production record reviews.
• Participate in investigations related to documentation errors, audit findings, and quality system issues.
• Assist with internal audits and support external regulatory and customer audits as required.
• Maintain accurate records of audit findings and quality metrics.
• Support document control activities, including controlled document reviews and revision verification.
• Monitor trends in documentation errors and provide recommendations for corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams to improve manufacturing documentation processes and enhance quality system effectiveness.
• Provide guidance and training to production personnel regarding documentation requirements and Good Documentation Practices.
• Support quality system initiatives and continuous improvement projects.
• Maintain a clean and safe working environment in accordance with company safety policies and OSHA requirements.

This is not an exhaustive list of duties or functions and may not necessarily comprise all essential functions of the position.

Education/Experience Required and/or Preferred

• High School Diploma or equivalent required.
• Associate Degree in Quality, Engineering Technology, Life Sciences, Manufacturing Technology, or related field preferred.
• Minimum of 2 years of experience in a regulated manufacturing, quality assurance, quality systems, or document control environment preferred.
• Experience in medical device manufacturing and familiarity with Device History Records preferred.
• Previous auditing or documentation review experience strongly preferred.

Knowledge, Skills, and Abilities

Technical Competencies

• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS).
• Ability to read, interpret, and follow manufacturing procedures, specifications, work instructions, and quality system documents.
• Understanding of Good Documentation Practices (GDP) and document control requirements.
• Knowledge of Device History Records (DHRs), production routers, and manufacturing records.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and medical device quality requirements preferred.
• Ability to identify documentation discrepancies and assess compliance risks.
• Experience reviewing batch records, production records, or manufacturing documentation preferred.
• Strong organizational skills with the ability to manage multiple audits and priorities simultaneously.
• Data entry and record review accuracy with a high degree of attention to detail.

Behavioral & Basic Skill Competencies

• Team player with the ability to work cooperatively with others.
• Positive attitude and commitment to quality.
• Strong active listening skills and ability to follow directions, learn, and adapt.
• Effective verbal and written communication skills across departments.
• Strong work ethic and punctuality.
• Exceptional attention to detail and documentation accuracy.
• Strong analytical, problem-solving, and critical-thinking skills.
• Ability to manage multiple priorities and meet deadlines.
• Ability to work independently while exercising sound judgment.
• Demonstrates integrity and accountability in quality-related decisions.
• Role model for compliance, quality, and safety expectations.
• Peer-to-peer mentoring and support of team development.
• Quality and patient-focused mindset.
• Commitment to continuous improvement and operational excellence.

Key Performance Indicators (KPIs)

• Accuracy and completeness of router audits.
• Timely completion of production record reviews.
• Documentation error detection and resolution rates.
• Compliance with audit turnaround times.
• Internal and external audit readiness.
• Contribution to quality system improvements and CAPA effectiveness.

Work Environment