At a Glance
- Tasks: Manage and control documentation in a cutting-edge medical tech environment.
- Company: Innovative medical technology organisation focused on quality and compliance.
- Benefits: Competitive salary, career growth, and a chance to work with industry leaders.
- Other info: Collaborative team environment with opportunities for professional development.
- Why this job: Be a key player in ensuring quality and compliance in life-saving technologies.
- Qualifications: Experience in document control and knowledge of ISO13485 standards.
Aurora Lifesciences client is an innovative medical technology organisation that is looking for an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment. The Senior Document Controller will support document lifecycle management, change control, audit readiness and compliance with ISO13485 and applicable regulatory requirements. The role will work closely with Quality, Regulatory, Manufacturing and Engineering teams to ensure documents are accurate, approved, traceable and available when required.
Key Responsibilities
- Process document, item and engineering change requests in line with approved change control procedures.
- Review change orders for accuracy, completeness and appropriate approvals.
- Manage the creation, review, approval, issue, revision, withdrawal and archiving of controlled documents.
- Ensure quality records are filed and retained in accordance with ISO13485 and internal procedures.
- Assign document numbers, revision levels and controlled identifiers.
- Maintain document registers, training matrices and associated training records.
- Ensure current document versions are available at the point of use.
- Monitor outstanding document reviews, approvals and change control activities.
- Retrieve records for internal audits.
Document Controller employer: Aurora Life Sciences
Aurora Lifesciences is an exceptional employer, offering a dynamic work environment within the innovative MedTech sector. Employees benefit from a strong commitment to quality and compliance, alongside opportunities for professional growth through continuous improvement initiatives and involvement in critical projects. Located in a thriving area for medical technology, the company fosters a collaborative culture that values employee contributions and encourages career advancement.
