Quality Assurance & Compliance Analyst

The Quality Assurance & Compliance Analyst is responsible for maintaining and supporting document control, training records, internal and external audits and corrective and preventive actions (CAPA) within the quality management system along with regular communication with ETQ.

This position is an on-site role.

Key Result Accountabilities

• Verify quality records meet customer and regulatory requirements.
• Ensure all documents pertaining to the Quality System are controlled and only the latest revisions are in use.
• Ensure retention and accessibility of quality records.
• Generate reports and metrics on quality system performance.
• Schedule Quality System training throughout the facilities as needed. Ensure proper training is conducted and provide training material for all departments as required.  Maintain current status of training database by updating revisions to documents, learning paths, or individual employee status and requirements, such as job transfers or cross-training.
• Support compliance with NADCAP requirements and special process controls where applicable.
• Administer the CAPA System, including Customer complaints, corrective / preventive actions, and supplier corrective actions. Track nonconformances, customer complaints, and root cause investigations.
• Assist departments in preparing for regulatory and customer audits.
• Track audit findings and ensure timely completion of corrective actions.
• Prepare audit reports and management review documentation.
• All other duties as assigned.

Requirements

• Associate's or Bachelor's degree in Quality Management, Engineering, Manufacturing, Business Administration, or a related field, preferred.
• 3–5 years of experience in quality systems administration, quality assurance, or manufacturing quality, preferred.
• Experience in quality management systems software, ETQ experience a plus. Must complete administrator training.
• Proficiency in Microsoft Office Suite, particularly Excel.
• Experience with FDA, ISO 13485 AS9100, and ISO 9001, ISO 14001 is a plus.
• Knowledge of quality tools such as FMEA, SPC, Control Plans, and Process Audits.
• Must work with a high attention to detail.
• Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
• Must possess excellent verbal & written communication skills.
• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.