Description:

Must haves:

Proficiency in Microsoft Office and Excel

Ability to follow written procedures

Detail oriented

Ability to work autonomously

This position is responsible for the development, maintenance, and management of Medical Device Files (MDFs) in accordance with ISO 13485 standards. This position will also be responsible for performing change controls, creating, and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.

Description of work:

• Developing, reviewing, maintaining, and updating medical device files in accordance with ISO 13485.

• Coordinating across functions (development, operations, engineering, and quality) to ensure that all necessary documentation is collected and properly recorded.

• Drive resolution on any non-compliance issues identified during creation of MDFs.

• Initiates change controls and document change requests to update procedures and processes.

• Supports or leads continuous improvement initiatives for quality management system processes.

• Other duties as required.

Minimum Qualifications:

• Associate or bachelor’s degree in life sciences, engineering, or a related field. 3+ years of experience in manufacturing environment is preferred.

Skills / Experience:

• Comprehensive knowledge of ISO 13485 and other relevant regulations and standards.

• Previous experience in the creation and management of Medical Device Files.

• Strong attention to detail and high levels of accuracy.

• Excellent documentation and record-keeping abilities.

• Strong communication and interpersonal skills.

• Ability to work cross-functionally and lead teams.

• Proficient in the use of document management systems.

• Experience as Internal auditor is preferred.

• Project management skills preferred.