QA Document Control Specialist

About you: 

Reporting to the QA Lead, the QA Document Control Specialist will be responsible for administering the Electronic Document Management System and Learning Management System, controlled document processing, assessing related training requirements, and tracking training compliance. The QA Document Control Specialist will ensure that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets. Additionally, this position will establish and modify comprehensive document control systems to be compliant with FDA cGMP Regulations (21 CFR Part 820) as well as ISO 13485 requirements. 

What you’ll do:

• Create and maintain documentation associated with the production of medical devices as per ISO 13485 and relevant regulatory requirements;

• Provide multi-departmental support related to product development and documentation;

• Provide support to the Supplier Quality Engineer to ensure adequate documentation for critical suppliers;

• Control the release of design and process documents through an electronic quality management system (eQMS);

• Support the document control, and change control process within the QMS;

• Assisting in the development of Quality Assurance work instructions and procedures;

• Provide company-wide training for Quality Assurance SOPs, as needed;

• Maintaining documents that record the status of equipment used in the design, development, and manufacturing of medical devices;

• Responding and tracking any corrective and preventive action (CAPA) that is recorded in the QMS from initiation to closure;

• Liaise with stakeholders regarding document approvals;

• Maintain and report on performance metrics for Document Control and Training.

What you’ll need:

• Bachelor’s degree in Science or Engineering;

• 1+ years of work experience in a QA function in an ISO 9001 or ISO 13485-certified environment;

• Excellent English written and oral communication skills;

• Inventory management systems set up and/or management; SOP writing experience; 

• Training experience;

• Experience managing electronic and paper quality management systems, document control systems, and learning management systems.

• Previous experience in current Good Manufacturing Practices (cGMP)) quality guidelines and FDA regulations including 21 CFR Part 11 and ISO 13485 requirements;

• Strong communication and ability to work cross-functionally to problem solve and improve processes and procedures;

• Ability to effectively work within a fast-paced team environment;

• Strong attention to detail, able to execute aggressive timelines;

• Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact.

Bonus points for:

• Experience supporting regulatory agency audits in a QC environment;

• Experience in regulatory requirements in various jurisdictions; 

• Experience with calibration systems setup and performing equipment calibrations;

• Experience in Excel and Word, including experience creating documents to be used on the manufacturing floor.

• Experience reviewing and updating Engineering Change Orders (ECOs) in a manufacturing environment.

About Vital

Vital is revolutionizing the landscape of point-of-care diagnostics with our groundbreaking platform, VitalOne, designed to deliver real-time care wherever patients are. We have built a dynamic team of experts across various disciplines including chemistry, software, engineering, and microfluidics to fulfill our mission of making healthcare more accessible and proactive. At Vital, we seek tenacious, bold, and enthusiastic individuals ready to create impactful change in the healthcare industry.