Document Controller - Fuze Services

LetsGetChecked; 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

Career Clinics to support progression

Parental and wedding leave

Flexible annual leave policy

Job summary

Fuze Health is seeking a detail-oriented Document Controller to join our Quality team at the Northern Cross facility in Dublin onsite. You will own document control and change control within the eQMS, ensuring accurate maintenance and approvals before publication.

Reporting to the Quality Manager, you will collaborate with department managers to ensure regulatory compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and ISO 14971, and coordinate training and records.

Qualifications

• A bachelor's degree.
• 1-2 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 accurate documentation and change control records.
• Analytical skills to assess impact of proposed changes and identify risks in QMS docs.
• Strong organizational and time management skills with ability to manage priorities.
• Excellent written and verbal communication and cross-functional collaboration.

Responsibilities

• Own and coordinate document control and change control activities within the eQMS.
• Ensure changes affecting the QMS are recorded, assessed and approved before implementation.
• Develop and maintain work instructions for document and change control processes.
• Coordinate meetings with process owners to review changes and actions.
• Organise change control review meetings and track outstanding actions.
• Review document submissions for accuracy and routing to reviewers.
• Ensure required approvals and training are completed before publication.
• Identify training requirements arising from new or revised documents.
• Maintain training matrices with Quality Manager and department managers.
• Deliver QMS induction training and onboard new employees to the eQMS.
• Maintain accurate quality records within the QMS.
• Support review of products, processes and quality docs against regulatory requirements.
• Escalate overdue actions and compliance risks to stakeholders.

Skills

Attention to detail

Documentation management

Regulatory compliance

Communication skills

Education

Bachelor's degree

Science/Engineering background

Tools

eQMS

Regulatory documentation systems

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

Benefits – Fuze Health

• 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.

#LI-Onsite

Equal Opportunity Employer

Fuze Health is an 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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