Senior QMSR Manager: Quality Systems & Compliance

CH01 CHE Fresenius Medical Care (Schweiz) AG; 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

Bonus eligibility

Job summary

Fresenius Medical Care in the United States is seeking an experienced Quality Systems Manager to oversee the development, implementation, and maintenance of the quality management system across manufacturing and testing operations.

You will lead cross-functional teams, manage budgets, and drive continuous improvement while ensuring compliance with FDA and ISO standards. A strong background in medical devices or pharma quality is required.

Qualifications

• Minimum 6–8 years in quality systems, preferably in medical devices or pharma.
• 3+ years in a managerial role with direct reports.
• Strong project management, budgeting, and leadership skills.
• Solid knowledge of FDA regulations (21 CFR Part 820/11) and ISO 13485.

Responsibilities

• Lead strategic quality initiatives and define metrics for program effectiveness.
• Oversee department budgets, schedules, and performance standards.
• Mentor staff, conduct performance reviews, and coordinate with HR.
• Ensure regulatory compliance and prepare for inspections/audits.

Skills

Quality systems leadership

Project management

Team leadership

Budgeting

Regulatory knowledge

Written & verbal communication

CAPA & nonconformances

Cross-functional collaboration

Education

Bachelor's Degree

CQE/CQA certification

Tools

SAP

Crystal reporting

MS Office

Job description

Fresenius Medical Care in the United States is seeking an experienced Quality Systems Manager to oversee the development, implementation, and maintenance of the quality management system across manufacturing and testing operations.

You will lead cross-functional teams, manage budgets, and drive continuous improvement while ensuring compliance with FDA and ISO standards. A strong background in medical devices or pharma quality is required.