Quality Document Controller - eQMS & Compliance

Fuze Health Inc.; United States; Vor Ort; USD 39.000 - 45.000; Vollzeit

Benefits dieser Stelle

Health insurance

Pension

Annual compensation reviews

Employee referral bonus programme

Careers Clinics and internal growth

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Analytical skills

Organisational skills

Written & verbal communication

Adaptability

Ausbildung

Bachelor's degree

Science/Engineering degree (Desirable)

Tools

eQMS experience

Jobbeschreibung

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.