Document Control Specialist

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

As part of our ongoing expansion in North America, we are seeking a meticulous and organized Document Control Specialist to manage our documents to ensure compliance with company policies, industry standards, and legal requirements. The ideal candidate will have excellent attention to detail, strong organizational skills, and experience with document management software.

This role is crucial for ensuring that all company documents are accurate, accessible, and compliant with regulatory standards

Major Responsibilities

Reporting to the Senior Manager, Quality Management Systems and Document Services, the Document Control Specialist will be responsible and accountable for:

• Manage and maintain all controlled company documents, including processing and recording revisions.

• Verify and ensure the accuracy and quality of documents.

• Update and control procedure documents and forms.

• Create and manage document hierarchy and process systems.

• Train employees in the use of controlled documents.

• Ensure all documents meet set standards in terms of quality and compliance.

• Coordinate activities related to the document control procedure, including the distribution of documents and ensuring access.

• Input document data into standard registers ensuring that the information is accurate and up-to-date.

• Implement and maintain document control processes and procedures.

• Develop and maintain a comprehensive filing system and computer database for all documents to be retained in the document control center.

• Manage the flow of documentation within the organization.

• Maintain confidentiality around sensitive documentation.

• Prepare reports and audits to help identify document inconsistencies.

• Ensure all documents are up-to-date and accurately reflect current policies and procedures.

• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Skills & Experience

• Demonstrable experience in a similar role, preferably within the medical technology / medical device industry

• Subject Matter Expert with document management software, preferably MasterControl or Trackwise.

• Proficiency in Microsoft Office Suite and other relevant software.

• Knowledge of industry standards and regulatory requirements.

• Familiarity with quality management systems.

Personal Attributes

• Strong organizational and multitasking skills.

• Excellent attention to detail and “do it right the first time” attitude

• Ability to prioritize and manage time effectively.

• Strong communication skills, both written and verbal.

• Ability to thrive in a fast-paced environment, adapt to change, and comfortably navigate ambiguity with confidence

Qualifications

• Bachelor’s degree in a scientific or technical discipline, or equivalent work experience

We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.