Sr. Quality & Process Transformation Engineer

Fresenius Medical Care; Waltham (MA); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Parental leave

Job summary

Fresenius Medical Care seeks a Sr. Process Excellence Engineer to drive QMS improvements, simplify processes, and harmonize global systems across NA sites. You will lead transformation initiatives, partner with Quality leaders, and ensure regulatory compliance while delivering measurable business value.

Responsibilities include governance, education, and collaboration to accelerate performance improvements and standardization across functions and regions.

Qualifications

• 7+ years in Quality, Quality Systems, or Process Improvement in regulated industries.
• Knowledge of QMSR and quality governance.
• Experience supporting regulatory inspections and audits.
• Familiarity with ISO 13485, ISO 14971, 21 CFR QSR Part 820, Health Canada, Brazil, China FDA, US FDA QMSR.

Responsibilities

• Drive process improvements and system simplification across NA sites and functions.
• Lead cross-functional initiatives to standardize and digitize QMS processes.
• Collaborate with quality leaders to enable compliant and efficient operations.
• Develop dashboards and governance structures for quality performance.

Skills

Quality systems

Process improvement

Regulatory inspections

QMS governance

Influence leadership

Cross-functional collaboration

Quality standards knowledge

Education

Bachelor's degree

Master's degree

CQE

CQA

Lean / Six Sigma training

Job description

Fresenius Medical Care seeks a Sr. Process Excellence Engineer to drive QMS improvements, simplify processes, and harmonize global systems across NA sites. You will lead transformation initiatives, partner with Quality leaders, and ensure regulatory compliance while delivering measurable business value.

Responsibilities include governance, education, and collaboration to accelerate performance improvements and standardization across functions and regions.