Quality Manager - Fuze Services

LetsGetChecked; United States; On-site; USD 93,000 - 99,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Referral bonus program

Internal opportunities and careerClin​

Flexible leave policy

LetsGetChecked flexible annual leave

Job summary

Fuze Health, in collaboration with LetsGetChecked, seeks a Quality Manager to implement best-practice QMS initiatives and provide cross-location leadership. You will model quality behaviors and drive development of others across sites.

The role requires extensive experience in medical device quality management, regulatory compliance, and leading improvement programs across locations, with travel as needed.

Qualifications

• Bachelor’s degree in Quality Management, Engineering, or a technical discipline (or equivalent practical experience).
• IRCA Certified Lead Auditor (EN ISO 13485:2016).
• 5+ years of experience as a Quality Manager in a medical device or IVD environment.
• Hands-on experience with medical device software and regulatory submissions is preferred.
• Formal training in Risk Management (EN ISO 14971:2019) is desirable.

Responsibilities

• Provide governance and leadership for QMS, ensuring compliance with EN ISO 13485:2016, 21 CFR 820, EU MDR/IVDR. Serve as PRRC and Management Representative.
• Oversee eQMS implementation, operation, and document/change control processes.
• Lead and develop Quality personnel; design and deliver QMS and capability training.
• Maintain Risk Management program and lead quarterly updates of risk files.
• Lead internal audits, participate in external/regulatory audits, and support management reviews.
• Drive CAPA, Kaizen, NCR processes and root-cause analysis for issue resolution.

Skills

Quality management

Regulatory compliance

Leadership

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in Quality Management or Engineering or technical discipline

IRCA Certified Lead Auditor (EN ISO 13485:2016)

Tools

eQMS platform

Regulatory submissions software

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.

The Quality Manager will be responsible for implementing best practice initiatives to improve process capability, and will provide ongoing leadership across locations. As a departmental leader you are expected to be a role model in exhibiting the quality behaviours and values of the company and continuously fostering the development of others.

Job Description

KEY RESPONSIBILITIES

• QMS Governance & Regulatory Compliance Serve as designated Management Representative and Person Responsible for Regulatory Compliance (PRRC) on behalf of the Director of Manufacturing Quality and Regulatory. Ensure site compliance with EN ISO 13485:2016, 21 CFR 820, EU MDR (2017/745), EU IVDR (2017/746), and applicable regional requirements.

• eQMS & Change Control Oversee the implementation, operation, and maintenance of the eQMS platform. Manage document and design change control processes to ensure compliance with company protocols.

• Team Leadership & Development Manage Quality personnel, allocating work and managing projects to achieve site goals. Design, assign, and lead comprehensive QMS, product, and capability training to embed problem prevention and quality standards across the organization.

• Risk Management Maintain and participate in the Risk Management program (EN ISO 14971), identifying critical‑to‑quality procedures for each product and leading quarterly risk file updates.

• Audits & Management Review Lead the internal audit program, participate in third‑party regulatory audits, and collate site management reviews across all locations to support QMS continuous improvement.

• CAPA & Continuous Improvement Drive quality performance using CAPA, Kaizen, NCR, and root‑cause analysis methodologies, focusing specifically on technical issue resolution and customer complaint reduction.

• Performance Reporting & Best Practices Maintain KPI reporting methodologies across all scoped locations. Collaborate with sister sites to share and establish quality management best practices.

• Operational & Project Execution Execute assigned projects (design and continuous improvement) within budget and schedule, incorporating Lean, Six Sigma, safety, and cost‑reduction principles.

• Site Support & Travel Travel nationally and internationally as needed, providing backup support to sister locations and performing additional duties as assigned.

QUALIFICATIONS & EXPERIENCE

Minimum Qualifications

• Bachelor’s degree in Quality Management, Engineering, or a technical discipline (or equivalent practical experience).

• IRCA Certified Lead Auditor (EN ISO 13485:2016).

• 5+ years of experience as a Quality Manager in a medical device or IVD environment.

Preferred Experience & Technical Skills

• Hands‑on experience with medical device software, electromechanical devices, sterilization processes, and regulatory submissions.

• Formal training in Risk Management (EN ISO 14971:2019).

• Proven leadership experience managing directly reporting teams.

• Experience working within controlled room / cleanroom environments.

• Strong cross‑functional collaboration skills (working with Regulatory Affairs, Engineering, and Materials).

CORE COMPETENCIES

• Customer Focus Understands internal and external customer needs, prioritizes prompt resolution, and makes business decisions with customer satisfaction in mind.

• Drive for Results Highly motivated to achieve quantifiable business outcomes. Bottom‑line oriented, understands organizational profitability, and acts with strict professional ethics.

• Adaptability Copes effectively with organizational change and workplace uncertainty, actively seeking clarification when needed and demonstrating openness to new procedures and technology.

• Creative Problem‑Solving Identifies root causes, recognizes operational patterns, and generates novel, effective solutions to complex issues.

• Cross‑Cultural Respect & Collaboration Respects diverse viewpoints and backgrounds, fostering strong, collaborative relationships across all levels of the business.

Additional Information

Salary and Benefits

Salary Range: €80,000 - €85,000

Benefits - 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].

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