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, controlling 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:

1. Create and maintain documentation associated with the production of medical devices as per ISO 13485 and relevant regulatory requirements;
2. Provide multi-departmental support related to product development and documentation;
3. Provide support to the Supplier Quality Engineer to ensure adequate documentation for critical suppliers;
4. Control the release of design and process documents through an electronic quality management system (eQMS);
5. Support the document control, and change control process within the QMS;
6. Assist in the development of Quality Assurance work instructions and procedures;
7. Provide company-wide training for Quality Assurance SOPs, as needed;
8. Maintain documents that record the status of equipment used in the design, development, and manufacturing of medical devices;
9. Respond to and track corrective and preventive actions (CAPA) recorded in the QMS from initiation to closure;
10. Liaise with stakeholders regarding document approvals;
11. Maintain and report on performance metrics for Document Control and Training.

What you’ll need:

1. Bachelor’s degree in Science or Engineering;
2. At least 1 year of work experience in a QA function within an ISO 9001 or ISO 13485-certified environment;
3. Excellent English written and oral communication skills;
4. Experience with inventory management systems setup and management; SOP writing experience;
5. Training experience;
6. Experience managing electronic and paper quality management systems, document control systems, and learning management systems;
7. Previous experience with current Good Manufacturing Practices (cGMP) quality guidelines and FDA regulations, including 21 CFR Part 11 and ISO 13485;
8. Strong communication skills and the ability to work cross-functionally to problem solve and improve processes and procedures;
9. Ability to work effectively in a fast-paced team environment;
10. Strong attention to detail and ability to meet aggressive timelines;
11. Good interpersonal skills for interacting with people at all levels with sensitivity and tact.

Bonus points for:

1. Experience supporting regulatory agency audits in a QC environment;
2. Knowledge of regulatory requirements across various jurisdictions;
3. Experience with calibration systems setup and performing equipment calibrations;
4. Proficiency in Excel and Word, including creating documents for manufacturing use;
5. Experience reviewing and updating Engineering Change Orders (ECOs) in a manufacturing environment.

About Vital

Vital is revolutionizing point-of-care diagnostics with our innovative platform, VitalOne, designed for real-time care delivery wherever patients are. We have assembled a diverse team of experts across chemistry, software, engineering, and microfluidics to advance healthcare accessibility and proactive treatment. We seek tenacious, bold, and enthusiastic individuals eager to make a meaningful impact in healthcare.

Vital Biosciences Inc. is an equal opportunity employer committed to diversity. We are happy to accommodate individual needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. Please contact us in advance if you require accommodation during the hiring process.