Senior Quality & Compliance Manager, Medical Devices

CH01 CHE Fresenius Medical Care (Schweiz) AG; Waltham (MA); On-site; USD 109,000 - 183,000; 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

CH01 CHE Fresenius Medical Care (Schweiz) AG seeks a Compliance Manager in Waltham, MA to lead and maintain company quality systems. You will coach staff, implement standards for inspection, testing, and product conformity, and report metrics to executives.

The role requires a bachelor's degree in science/engineering, 6–8 years in quality systems within medical devices/pharma, and strong FDA, cGMP/QSR, and ISO 13485 knowledge. Travel up to 10% is expected.

Qualifications

• Bachelor's Degree required, preferably in a scientific or engineering discipline; Advanced Degree desirable.
• Minimum 6-8 years of related quality systems experience in a medical device/pharmaceutical environment.
• 3+ years of supervisory experience preferred.
• Knowledge of US cGMP/QSR, ISO 13485, and related Quality standards.
• Strong knowledge of FDA regulatory requirements and quality assurance practices.

Responsibilities

• Oversee the development and maintenance of quality systems and staff.
• Lead corrective actions to ensure conformity with quality standards and regulatory requirements.
• Collaborate with internal/external resources to resolve medium to high complexity quality issues.
• Report quality metrics to senior management and support strategic decisions.
• Travel up to 10% as needed and supervise multiple teams.

Skills

Verbal communication

Written communication

Leadership

Attention to detail

Interpersonal skills

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Job description

CH01 CHE Fresenius Medical Care (Schweiz) AG seeks a Compliance Manager in Waltham, MA to lead and maintain company quality systems. You will coach staff, implement standards for inspection, testing, and product conformity, and report metrics to executives.

The role requires a bachelor's degree in science/engineering, 6–8 years in quality systems within medical devices/pharma, and strong FDA, cGMP/QSR, and ISO 13485 knowledge. Travel up to 10% is expected.