Senior Quality Systems & Compliance Leader

Freseniusmedicalcare; Waltham (MA); On-site; USD 122,000 - 205,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Parental leave

Bonus potential

Job summary

Fresenius Medical Care seeks a senior leader to develop, implement, and maintain the company’s Quality Management System in Massachusetts. You will oversee standards, methods, and procedures for inspection, testing, and evaluation of products to ensure conformance with regulatory requirements.

The role requires strong leadership, project management, and deep knowledge of FDA/ISO quality systems, CAPA processes, and regulatory readiness.

Qualifications

• Bachelor’s degree required in science, engineering, quality management or related field.
• Professional quality discipline certification desired (CQE, CQA, CQM or RAB).
• Experience in medical device or pharmaceutical quality systems.

Responsibilities

• Lead and oversee quality systems programs and metrics.
• Coach and develop direct reports; partner with HR on staff matters.
• Interpret policies and implement strategic quality procedures.
• Develop and monitor department budgets, schedules and standards.
• Analyze quality data trends and report KPIs.
• Ensure regulatory compliance with FDA/ISO requirements.

Skills

Quality systems

Regulatory compliance

Project management

Leadership

Analytical skills

Communication

Microsoft Office

SAP experience

Education

Bachelor's Degree in Science/Engineering/Quality

CQE/CQA/CQM or RAB certification

Professional association membership (PDA/AMMI/ASQ)

Tools

SAP

Crystal reporting

Job description

Fresenius Medical Care seeks a senior leader to develop, implement, and maintain the company’s Quality Management System in Massachusetts. You will oversee standards, methods, and procedures for inspection, testing, and evaluation of products to ensure conformance with regulatory requirements.

The role requires strong leadership, project management, and deep knowledge of FDA/ISO quality systems, CAPA processes, and regulatory readiness.