Quality Engineer - Fuze Services - Fixed Term Contract

About Fuze Health

Fuze Health is dedicated to prioritizing patients and addressing critical healthcare challenges by enabling millions to connect digitally with healthcare providers, resources, and treatments. We empower various stakeholders including care providers, employers, health plans, and life sciences companies to enhance quality, outcomes, and value. Our company consolidates the strengths of industry leaders like LetsGetChecked, Truepill, and Alto Pharmacy into one innovative healthcare organization, aiming to deliver next-generation solutions to meet emerging patient and market demands.

Role Overview

We are looking for a meticulous Quality Engineer to join our manufacturing team based in Dublin 11 on a 12-month fixed-term contract. The successful candidate will ensure our products and processes adhere to regulatory standards such as ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and ISO 14971. You'll support change controls, review validations of manufacturing equipment and processes, lead risk management efforts, and actively participate in internal and external audits. Collaboration with cross-functional teams across the product lifecycle is a key part of this role.

Key Responsibilities

• Continuously assess products and processes for compliance with relevant medical device regulations and standards.
• Support and review change controls and design modifications to maintain compliance during change implementation.
• Review and approve validation outputs related to equipment and processes, aiding in effective process control implementation.
• Participate in audit preparations, support audit activities, and coordinate responses to audit findings with process owners.
• Lead and maintain risk management documentation, analyzing potential failures, defect impacts, and mitigation strategies.
• Work collaboratively to implement changes and automation with accuracy and efficiency.
• Manage customer complaints, ensuring corrective actions are implemented and followed up adequately.
• Analyze potential issues affecting customer safety and product quality, aiding in decisions on non-conforming product disposition.
• Assist investigations into CAPAs and non-conformances, managing recordkeeping through critical project phases.
• Stay informed about regulatory updates and best industry practices, integrating quality principles and offering solutions to operations and engineering teams.

Candidate Profile

• Possess between 2 to 5 years of relevant experience in medical device quality departments.
• Hold a Bachelor’s degree in Biomedical Engineering, Quality Management, or a related field; a Master’s degree is advantageous.
• Solid understanding of ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971, IEC 62366, GAMP5 standards and regulations.
• Experience supporting new product introductions (Class II devices, Class A IVDs, Procedure Packs) with knowledge of manufacturing engineering procedures, risk analysis, and risk management documentation.
• Familiarity with supplier, internal, and external audits; auditing certification is a plus.
• Skilled in reviewing technical documents, assessing impacts on Quality Management Systems, and supporting post-market surveillance collaboratively.
• Knowledgeable in root cause analysis, continuous improvement processes, and effectiveness verification.
• Exposure to statistical tools, Lean, Six Sigma methodologies; experience with Minitab is preferable.
• Strong organizational abilities to manage projects and foster a positive team environment.
• Able to perform effectively in a fast-paced manufacturing setting, multitask, and meet tight deadlines.
• Demonstrates teamwork skills and promotes a culture that values quality as a competitive advantage.
• Experience using ERP systems, ideally SAP S/4 HANA with Quality Management module.
• Essential communication capabilities including analytical thinking, technical writing, troubleshooting, and verbal communication.

Additional Details

Salary: €60,000 to €68,000 per year.
Benefits:

• Comprehensive health insurance plus Employee Assistance Program.
• Company pension scheme.
• Annual salary reviews.
• Referral bonus incentives for recruiting talented individuals.
• Internal career development opportunities including clinics to support advancement.
• Maternity, paternity, parental leave, and wedding leave offered.
• Flexible annual leave policy.

Equal Employment Opportunity

Fuze Health is an equal opportunity employer committed to non-discrimination on legally protected bases such as race, gender, religion, national origin, disability, veteran status, sexual orientation, and more. We provide reasonable accommodations for applicants with disabilities and comply with applicable fair chance laws regarding background checks.

Use of Automated Decision Tools

Recruiters and managers may use automated tools to assist in assessing candidate qualifications based on resume data, ensuring a fair and objective hiring process; however, no hiring decisions are made solely by automated means.

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