Quality Engineer - Fuze Services - Fixed Term Contract

Let'sGetChecked; Ireland; On-site; EUR 60,000 - 68,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Referral programme

Onsite clinics

Job summary

Fuze Health, in partnership with LetsGetChecked, seeks a Quality Engineer to join our Dublin-based manufacturing facility and ensure compliance with ISO13485, 21CFR Part820, MDR, IVDR and related standards. This 12-month fixed-term contract involves change controls, validations, audits, and risk management within a fast-paced medical device environment.

Key responsibilities include supporting audits, leading risk management activities, reviewing validation deliverables, and driving continuous

Qualifications

• Bachelor's degree in Biomedical Engineering, Quality Management or related disciplines.
• 2–5 years of quality dept experience in medical devices.
• Working knowledge of ISO13485, 21CFR Part820, MDR2017/745, IVDR2017/746, ISO14971.

Responsibilities

• Evaluate products and processes for compliance with applicable regulations and standards.
• Review and support change controls and design changes to maintain compliance.
• Review and approve validation deliverables for equipment and processes.
• Participate in internal and external audits and assist in audit findings resolution.
• Lead risk management activities and maintain risk documentation.
• Collaborate with cross-functional teams to implement changes and automated systems.
• Handle customer complaints and ensure corrective actions are followed up.
• Assist in CAPA investigations and non-conformances, drafting necessary records.
• Stay updated on regulatory changes and advise on quality improvements.

Skills

Quality Assurance

Regulatory compliance

Audit support

Risk management

Cross-functional collaboration

Documentation

Education

Bachelor's in Biomedical Engineering/Quality Management

Tools

SAPS/4HANA QM

Job description

Job Summary

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.

Quality Engineer - Fuze Services

We are seeking a detail-oriented Quality Engineer to join our dynamic team at our Manufacturing Facility in Dublin to ensure our products and processes comply with relevant regulations and standards, including ISO13485, 21CFR Part820, MDR2017/745, IVDR2017/746, and ISO14971. This role involves supporting change controls, participating and reviewing validations related to manufacturing equipment and processes, supporting and contributing to internal and external audits, leads risk management activities, and collaborating closely with the teams involved in the product life cycle. This is a 12Months Fixed Term Contract, based onsite in our Dublin11 facility.

Job Description

Responsibilities

• Evaluate current products and processes to ensure ongoing compliance with applicable regulations and standards such as ISO13485, 21CFR Part820, MDR2017/745, IVDR2017/746, and ISO14971
• Review and support change controls/design changes, assisting the team through the change process to maintain compliance
• Review and approval of validation deliverables for equipment and processes, and assist in implementing effective process controls
• Participate in internal and external audits, supporting audit preparation and the resolution of audit findings by liaising with process owners and managers
• Lead risk management activities, maintain risk management documentation, and help assess risk mitigation techniques, potential failure modes, defect frequency, severity, and process controls
• Collaborate with cross-functional teams to implement changes and automated systems with efficiency and accuracy
• Responsible for customer complaint handling including the implementation and follow up of corrective actions
• Assist in analysing and summarising potential issues by assessing the impact on customer safety and product quality, and contribute to decisions related to the disposition of non-conforming product
• Support the investigation of CAPAs and non-conformances, drafting and reviewing applicable records and documentation for completion at critical phases
• Stay updated on regulatory changes and industry best practices, integrating quality into all aspects of work, and offering problem-solving recommendations to the operations and engineering teams

What are we looking for?

Experience: 2–5 years of relevant experience in a quality department within the medical device industry.

Education

Bachelor’s degree in Biomedical Engineering, Quality Management, or relevant disciplines (a Master’s degree is an advantage).

Working Knowledge

Working knowledge of ISO13485, 21CFR Part820, MDR2017/745, IVDR2017/746, ISO14971, IEC62366, GAMP5, and other applicable industry standards & regulations.

Experience and Skills

Experience supporting new product introductions (ClassII medical devices, ClassA IVDs, Procedure Packs) and knowledge of manufacturing engineering, risk analysis, and documenting risk management files/reports.

Exposure to supplier, internal, and external audits (a professional certification in auditing is a plus).

Experience reviewing technical documentation, assisting in assessing the impact of proposed changes on the QMS, and supporting post-market surveillance activities by working constructively with stakeholders.

Knowledge of root cause analysis, continuous improvement activities, and execution/verification of effectiveness.

Familiarity with Statistics, Lean, and Six Sigma methodologies; Minitab experience is an advantage.

Strong organizational skills with the ability to support project management initiatives and foster a positive work environment.

Ability to work effectively in a fast-paced medical device manufacturing environment, multi-task, and prioritize tasks to meet high expectations and tight deadlines.

Culture

Ability to work well within cross-functional teams and promote a 'Quality Culture' where compliance is viewed as a competitive advantage.

Experience using ERP systems such as SAPS/4HANA (Quality Management [QM] module preferred).

Strong analytical, troubleshooting, process improvement, technical writing, and verbal communication skills.

Additional Information

Salary and Benefits

• Salary Range: €60,000 - €68,000
• Fuze Health Health insurance and an Employee Assistance Programme
• Pension
• Annual Compensation Reviews
• A referral bonus programme to reward you for helping us hire the best talent
• Internal Opportunities and Careers
• Clinics to help you progress your career within the company
• Maternity, Paternity, Parental and Wedding leave
• LetsGetChecked has a flexible annual leave policy
• #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].

Privacy Notice

To learn about Fuze Health’s privacy practices, including compliance with applicable privacy laws, please read our Privacy Notice for Job Applicants.

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.