Quality System Specialist

Overview

The Coordinator 2, Quality Systems plays a key role in maintaining compliance and supporting the integrity of the company’s Quality Systems. This position is responsible for ensuring GxP records are properly managed and accessible, while contributing to the effectiveness of core quality processes, specifically managing quality event processes and supporting complaint handling. The role requires strong attention to detail, organizational skills, and the ability to collaborate across teams to uphold regulatory standards and company procedures.

• Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance.
• Sort and categorize records in alignment with retention schedules, regulatory requirements, and company procedures.
• Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability.
• Support complaint handling processes by accurately entering product complaint data into the system.
• Assist with the maintenance and issuance of controlled logbooks.
• Provide support across Quality System areas, including audits, CAPAs, document control, and training activities.
• Perform additional duties as assigned to meet departmental and organizational objectives.

• High School Diploma (or equivalent) with 4+ years of experience in life sciences or medical device industry.
• Strong foundation in records management and regulatory compliance.
• Familiarity with Master Control or similar Quality Management Systems.
• Broad experience in Quality functions, including customer complaint processes.
• Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards.
• Demonstrates integrity, self-confidence, and commitment to prioritizing customer and patient safety.
• Excellent interpersonal skills; able to collaborate effectively across all organizational levels.
• Strong work ethic with a proactive approach—eager to learn, take on new responsibilities, and seek additional tasks when available.

Physical Activities:

On a continuous basis, remain seated at a desk for extended periods of time; intermittently answer the telephone and type on a computer.

The role may also require periods of standing and walking, as well as lifting and carrying objects weighing up to 20–30 lbs.

The noise level in the work environment is usually low to moderate.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.