Description

You will own the quality management system documentation, change controls, and internal audits to ensure regulatory compliance.

Responsibilities

• Generate and maintain division-level quality documents, including procedures, work instructions, and certificates of conformance.
• Initiate change controls and document change requests to update site-level processes.
• Execute internal audits as a lead auditor for the division audit program.
• Perform root cause analysis to support the completion of CAPAs.
• Monitor quality system metrics and support continuous improvement initiatives.

Required Skills

• Knowledge of ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Experience with Quality Management Systems (QMS).
• Internal auditor experience or formal training.
• Proficiency in Microsoft Office.
• Ability to apply mathematical concepts including percentages, ratios, and proportions.
• Experience working across matrix organizations and with external consultants.
• Bachelor’s degree with 3+ years of equivalent experience, or a Master’s degree with 1+ years of equivalent experience.

Preferred Skills

• Experience using ETQ software.
• Background working in a manufacturing environment.

Key Skills

Education

Not specified