Senior Quality Systems Manager - Medical Devices

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Paid time off

Parental leave

Job summary

Fresenius Medical Care seeks a senior Quality Systems leader to develop, implement, and oversee the company’s quality framework. You will manage CAPA programs, audits, and regulatory compliance while guiding budgets, staffing and performance expectations to ensure products meet FDA and ISO standards.

The role requires extensive experience in medical device or pharmaceutical quality systems, strong leadership and data analysis skills, and collaboration with cross-functional teams to drive

Qualifications

• Bachelor's degree in a science/engineering/quality field required.
• 6–8 years in quality systems; 3+ years in managerial role preferred.
• Knowledge of FDA 21 CFR 820/210/211, ISO 13485, and CMDR is essential.

Responsibilities

• Lead development and maintenance of the quality systems and metrics across the organization.
• Provide leadership, coaching, and development for direct reports; partner with HR.
• Drive CAPA, audits, and regulatory compliance to ensure product quality.

Skills

Quality systems management

Leadership

Regulatory compliance

CAPA management

Data analysis

Project management

Communication

Auditing

Training design

Education

Bachelor's degree in Science/Engineering/Quality

CQE/CQA/CQM or RAB certification

Member of PDA/AMMI/ASQ

Tools

SAP

Crystal reporting

Microsoft Office

Job description

Fresenius Medical Care seeks a senior Quality Systems leader to develop, implement, and oversee the company’s quality framework. You will manage CAPA programs, audits, and regulatory compliance while guiding budgets, staffing and performance expectations to ensure products meet FDA and ISO standards.

The role requires extensive experience in medical device or pharmaceutical quality systems, strong leadership and data analysis skills, and collaboration with cross-functional teams to drive