Quality Systems & Compliance Manager

Fresenius Medical Care; Waltham (MA); On-site; USD 109,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off and parental leave

Job summary

Fresenius Medical Care seeks a senior quality systems leader to manage and optimize our company quality programs across multiple sites. This role drives compliance with US FDA regulations and international quality standards, mentors staff, and partners with cross-functional teams to resolve complex quality issues.

Candidates should have 6–8 years in quality systems within medical devices or pharmaceuticals and proven supervision.

Qualifications

• 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.

Responsibilities

• Directs tactical execution of quality systems objectives with oversight of results, costs, methods, and staffing.
• Leads, coaches, and develops direct reports in collaboration with HR.
• Oversees development and implementation of quality inspection/testing standards.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Training/coaching

Project management

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree desirable

Tools

Microsoft Office

Job description

Fresenius Medical Care seeks a senior quality systems leader to manage and optimize our company quality programs across multiple sites. This role drives compliance with US FDA regulations and international quality standards, mentors staff, and partners with cross-functional teams to resolve complex quality issues.

Candidates should have 6–8 years in quality systems within medical devices or pharmaceuticals and proven supervision.