Quality Assurance Documentation Manager

4 days ago

Oakville, Ontario, Canada Vitalbio Full time

**Job Overview:**

Vitalbio is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the accuracy and integrity of our documentation processes.

You 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.

In this role, you will ensure that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets.

Responsibilities:

  • 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;
  • Control the release of design and process documents through an electronic quality management system (eQMS);
  • Maintain documents that record the status of equipment used in the design, development, and manufacturing of medical devices;
  • Liaise with stakeholders regarding document approvals;
  • Maintain and report on performance metrics for Document Control and Training.

Requirements:

  • 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;
  • 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 skills 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.

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