Description

You will manage electronic document control, quality management system data analysis, and regulatory compliance support.

This role is on-site.

Responsibilities

• Evaluate Change Orders against procedure requirements and standards.
• Track product documentation status and analyze data from QMS processes.
• Perform documentation queries through computerized systems.
• Maintain accurate and orderly files for current and historical documents.
• Support regulatory audits and inspections as needed.

Required Skills

• 10+ years of experience in quality or documentation roles.
• Strong familiarity with cGMP and FDA guidelines for medical devices.
• Proficiency in Oracle, SQL, Power Query, and Visual Basic.
• Experience writing clear and concise technical documentation.
• Understanding of product specifications and their structure.
• Ability to learn and adapt to departmental procedures and industry best practices.
• Excellent verbal and written communication skills.
• Strong organizational skills with attention to detail.

Preferred Skills

• Experience supporting regulatory audits and inspections.
• Background in medical device quality assurance.

Key Skills

Education

Any Graduate