Document Control Specialist I

Basic Function

Maintain and implement a change management system in support of quality systems and practices to meet Imricor, customer, and regulatory requirements. Support cross functional engineering, production, and Quality activities through creation, verification, and coordination of quality documentation. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

• Provide documentation and change management support to ensure that company procedure requirements are met.
• Distribute and maintain official copies of documentation.
• Maintain training records and ensure training is current.
• Contribute to departmental improvement projects.
• Collaborate with Quality team to update and maintain Document Control procedures and quality management system.
• Prepare and deliver training to the rest of the company.
• Support audit activities, both internal and external.
• Perform other related duties and responsibilities, on occasion, as assigned.

Minimum Qualifications

· Associate’s or Bachelor’s degree and 0-2 years of relevant experience.

· Strong communication skills, both verbal and written.

· Ability to own and drive process improvements/projects and work cross functionally.

· Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.

Preferred Qualifications

· Medical device industry or other GMP Document Control experience.

· Knowledge of Quality System Document and Data Control requirements.

· Experience with technical documentation: Engineering Change Orders, Standard Operating Procedures, Work Instructions, Forms.

· Data Analytics knowledge.

Working Conditions

· Light work, exerting up to 20 lbs. of force or less.

· Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.

· Requires typing, talking and hearing.

· 85% of time requires viewing and working at computer screen.

· Travel < 5%