Senior Quality Systems Leader

Fresenius Medical Care; Waltham (MA); On-site; USD 122,000 - 205,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid time off

Parental leave

Job summary

Fresenius Medical Care seeks a Quality Systems leader to develop and maintain quality programs, ensuring conformity with government and company standards. You will lead teams, manage budgets, and drive regulatory compliance across sites.

The role requires 6–8 years in quality systems, with CQE/CQA/CQM or RAB certification preferred and experience with FDA/ISO requirements. Strong communication and strategic thinking are essential.

Qualifications

• Bachelor's degree required in a science/engineering/quality field.
• Professional quality discipline certification (CQE/CQA/CQM or RAB) desired.
• Experience with FDA/ISO regulatory requirements and CAPA management.

Responsibilities

• Oversee development and maintenance of quality systems and standards.
• Lead, coach, and develop Quality Systems staff; manage budgets and staffing.
• Review regulatory requirements and ensure compliance across sites and functions.
• Develop and monitor metrics and KPIs for program effectiveness.
• Interact with internal departments and external partners to resolve quality issues.

Skills

Quality Systems

Leadership

Budgeting

Regulatory Knowledge

CAPA & NC

Communication

Education

Bachelor's Degree in Science/Engineering/Quality Management

CQE/CQA/CQM or RAB certification

Tools

SAP

Crystal Reporting

MS Office

Job description

Fresenius Medical Care seeks a Quality Systems leader to develop and maintain quality programs, ensuring conformity with government and company standards. You will lead teams, manage budgets, and drive regulatory compliance across sites.

The role requires 6–8 years in quality systems, with CQE/CQA/CQM or RAB certification preferred and experience with FDA/ISO requirements. Strong communication and strategic thinking are essential.