Quality Docs Specialist – Medical Devices, Dublin (Onsite)

LetsGetChecked Inc.; 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

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.