Job Description

The Quality Systems Analyst will be responsible for developing and implementing quality systems in alignment with business, regulatory, and customer requirements. The role involves monitoring compliance with quality standards, conducting internal audits, managing document control, and supporting audits by regulatory bodies. The analyst will also coordinate with various departments to promote continuous quality improvement and ensure adherence to federal, state, and company regulations.

Responsibilities

• Deploy and monitor Quality Management Systems (QMS) based on industry standards and company policies
• Conduct internal audits to assess compliance with FDA and ISO standards
• Lead or assist in quality improvement initiatives and root cause analysis
• Use statistical tools to monitor quality metrics and process capability
• Maintain and manage records per internal and regulatory retention policies
• Support and prepare for FDA, customer, and notified body audits

Requirements

• Bachelor’s degree or equivalent experience
• 3–6 years of experience in Quality Systems, preferably in FDA-regulated industries
• Strong knowledge of 21 CFR Part 820, ISO 13485; familiarity with ISO 14971
• Excellent verbal and written communication skills
• Proficient in Microsoft Office (Word, Excel, Outlook, Access)
• Strong problem-solving, multi-tasking, and project management abilities