Document Controller

Fuze Health; United States; On-site; USD 39,000 - 45,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Employee referral bonus programme

Careers Clinics and internal growth

Job summary

Fuze Health Inc. is seeking a detail-oriented Document Controller for the Fuze Services Quality team at our Northern Cross facility in Dublin. You will own document and change control within the eQMS, ensuring changes are reviewed, approved and appropriately trained before release.

You will collaborate with department managers to maintain training, controls and quality records, supporting compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745 and related standards.

Qualifications

• Bachelor's degree required.
• 1–2 years in document control/change control in medical device or pharma.
• Basic understanding of ISO 13485:2016 and FDA 21 CFR Part 820.
• Familiarity with eQMS and regulatory standards is a plus.

Responsibilities

• Own and coordinate document control and change control in the eQMS.
• Ensure changes are recorded, assessed and approved before implementation.
• Develop work instructions for document/change control processes.
• Coordinate meetings with process owners to review changes and actions.
• Organise change control review meetings and track actions to KPIs.
• Review submissions for accuracy and routing to reviewers.
• Confirm approvals and training before publication of documents.
• Identify training needs arising from new or revised documents.
• Maintain training matrices with the Quality Manager.
• Deliver QMS induction and onboarding to the eQMS.
• Maintain accurate quality records in the QMS.
• Support review of products and processes against regulatory requirements.
• Escalate overdue actions and potential compliance risks.

Skills

Attention to detail

Analytical skills

Organisational skills

Written & verbal communication

Adaptability

Education

Bachelor's degree

Science/Engineering degree (Desirable)

Tools

eQMS experience

Job description

Job Summary About Fuze Health

At Fuze Health, we put patients first and tirelessly address the most pressing needs in healthcare. We empower millions to digitally connect with care providers, essential health resources and needed treatments - and enable care providers, employers, health plans and life sciences companies to meaningfully enhance quality, outcomes and value. We are dedicated to helping our partners evolve and modernize to meet emerging patient and marketplace needs. Fuze Health's foundation is built upon the strategic combination of several proven, technology-powered innovators in the digital health, diagnostics, and pharmacy sectors. Our growing portfolio brings together the capabilities of industry leaders including LetsGetChecked, Truepill, and Alto Pharmacy, to create a distinctive, unified force in healthcare. Together, we have the shared vision, advanced capabilities and talented teams to deliver next-generation solutions that patients and healthcare partners need today and into the future.

Job Summary

We are seeking a detail-oriented Document Controller to join our Fuze Services Quality team, based onsite at our Northern Cross facility in Dublin. Reporting to the Quality Manager, you will own the document control and change control processes within our electronic Quality Management System (eQMS). Working closely with department managers and process owners, you will ensure quality documentation is accurately maintained, changes are appropriately reviewed and approved, and required training is completed before documents are released. You will support compliance with applicable regulatory requirements and standards, including ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, EU IVDR 2017/746 and ISO 14971.

Job Description Responsibilities

• Own and coordinate document control and change control activities within the eQMS.
• Ensure changes affecting the Quality Management System are recorded, assessed and approved through the change control process before implementation.
• Develop and maintain work instructions supporting the effective use of document control and change control processes.
• Coordinate meetings with process owners to review proposed changes, assess their impact and agree required actions.
• Organise change control review meetings, track outstanding actions and support achievement of process KPIs.
• Review document submissions for accuracy and completeness, ensuring they are routed to the appropriate reviewers and approvers.
• Confirm that required approvals and applicable training are completed before documents are published.
• Work with department managers and process owners to identify training requirements arising from new or revised documents and processes.
• Maintain role-based training requirements and matrices in collaboration with the Quality Manager and relevant department managers.
• Deliver QMS induction training and onboard new employees to the eQMS.
• Maintain accurate, complete and traceable quality records within the Quality Management System.
• Support the review of products, processes and quality documentation against applicable regulatory and quality requirements.
• Escalate overdue actions, documentation issues and potential compliance risks to the Quality Manager and relevant stakeholders.

What Are We Looking For?

Essential

• A bachelor's degree.
• One to two years of experience in document control and change control within the medical device or pharmaceutical industry.
• A basic understanding of ISO 13485:2016 and FDA 21 CFR Part 820.
• Strong attention to detail, with the ability to maintain accurate documentation and comprehensive change control records.
• Analytical skills to assess the impact of proposed changes and identify potential risks or conflicts within QMS documentation.
• Strong organisational and time management skills, with the ability to manage competing priorities and work with minimal supervision.
• Excellent written and verbal communication skills, with the ability to collaborate across functions and elevate issues appropriately.
• A flexible approach and the ability to adapt to changing priorities and business requirements.

Desirable

• A degree in Science, Engineering or a related discipline.
• Experience using an eQMS to manage controlled documents, change controls and training records.
• Familiarity with EU MDR 2017/745, EU IVDR 2017/746 and ISO 14971.

Additional Information Salary and Benefits

• Salary: €35,000-€40,000
• Health insurance and an Employee Assistance Programme.
• Pension.
• Annual compensation reviews.
• Employee referral bonus programme.
• Internal opportunities and Careers Clinics to support career progression.
• Maternity, paternity, parental and wedding leave.
• Flexible annual leave policy.

This role is based onsite at our Northern Cross facility in Dublin.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected basis.

If you have a disability and require reasonable accommodation during any portion of the application or hiring process, please contact us at [e-mail].

Fuze Health considers qualified applicants with arrest or conviction records for employment and conducts background checks consistent with applicable law, including the California, Los Angeles County, San Francisco, Philadelphia, and New York City Fair Chance laws.

We are an E-Verify participating company.

Use of Automated Decision Tools

Fuze Health recruiters and hiring managers may use automated decision tools to help identify candidates who match the stated job requirements, and to what extent. These tools are designed to help ensure fairness in all aspects of the hiring process by providing recruiters and hiring managers with data-backed insights based on information provided in your resume, including work experience, education, and other skills.

Fuze Health does not use automated decision tools to make hiring decisions; hiring decisions always involve human review and input. If you have any questions or would like to request an alternative process, please contact us at [e-mail].

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