Sr Quality Process Excellence Engineer

Fresenius Medical Care AG; 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

PURPOSE AND SCOPE:

The Sr. Process Excellence Engineer, is responsible for driving process improvements, system improvements, standardization, harmonization, and transformation across QMS North America sites & functions (FMCNA), with a primary focus on improving QMS, Global Management Systems (GMS), and associated quality and business systems.

The position serves as a process change leader and liaison, ensuring Quality processes enable compliance, operational excellence, and continuous improvement while meeting regulatory requirements and business expectations. This role focuses on simplification and improving the ways we work both locally and globally while ensuring compliance with global and business requirements. In addition, this role focuses on how regulatory processes/systems and business processes/systems are working in synch to ensure delivery of effective solutions to advance the cause of quality and business objectives.

This role actively participates in QMS related functions and areas such as North America (NA) QMS activities, audit and inspection preparations, international QMS (CQMS) and GMS. This role has the authority, ownership, and responsibility to instruct functional leaders to jointly assess, design, implement, and sustain efficient, compliant, and scalable quality processes and systems that deliver value and impact. The role interfaces with multiple local and global departments and stakeholders to ensure alignment of local and global processes and improve collaboration across.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Drive process improvements and changes by working collaboratively with all stakeholders – while driving simplicity in QMS and its processes and systems.
• Breakdown complex and complicated processes and systems and reconnect to make it simple and effective while maintaining its compliance requirements.
• Understand the requirements, standards, and regulations well and know how to interpret and apply them appropriately to ensure solutions are implemented to meet both functional and business goals and objectives.
• Provide feedback at different reviews and meetings to drive process optimization and simplification.
• Provide solutions to stakeholders regarding processes and systems to drive right changes.
• Evaluate and drive changes on SOPs, policies, and procedures for measurable improvements.
• Collaborate with all employees to drive education and training of process requirements, improvements, and application.
• Collaborate with all employees to address areas of improvement and speed up the overall performance and execution.

Leadership & Collaboration

• Carry out process and system changes and improvements.
• Influence and partner with Quality and functional leaders without direct authority.
• Act as a trusted advisor and driver on quality process strategy and transformation.
• Facilitate cross-functional and cross-regional alignment and decision‑making to drive changes.
• Mentor teams and leaders on process excellence and continuous improvement principles.

Quality Management System (QMS) Process Improvement

• Drive continuous improvement of QMS processes in NA in partnership with QMS owners and global quality teams.
• Assess QMS usability, efficiency, and alignment with regulatory and enterprise standards.
• Lead initiatives to simplify, harmonize, and digitize QMS processes and documentation.
• Ensure effective integration of QMS elements.
• Ensure QMS meets the needs of business and enables desired outcomes, while being compliant.

Management Controls & Governance

• Design and implement management control frameworks to provide visibility into quality process performance and risk.
• Partner with Quality leadership to establish governance structures.
• Develop dashboards and reporting mechanisms for leadership review and decision‑making.
• Ensure clear accountability, escalation paths, and decision criteria are embedded in quality processes.

Quality Transformation & Continuous Improvement

• Lead quality transformation initiatives using Lean, Six Sigma, and continuous improvement methodologies.
• Identify opportunities to significantly reduce complexity, improve cycle times, and enhance process effectiveness.
• Champion the use of digital tools, automation, and analytics to improve quality processes.
• Drive change management, stakeholder engagement, and adoption of new ways of working.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• The employee is occasionally required to lift or move up to 25 pounds.
• The work environment is similar to that of any medical device / drug manufacturer and would have no impact on the employee to perform the essential functions of this job.

EDUCATION:

• Bachelor’s degree required (Science, Engineering, or related field).
• Professional quality discipline certification is a plus (e.g., CQE, CQA).
• Master’s degree preferred.
• Training in lean and/or six sigma practices a plus.

EXPERIENCE AND REQUIRED SKILLS:

• 7+ years of experience in Quality, Quality Systems, or Process Improvement in regulated industries.
• Knowledge of QMSR.
• Deep experience with QMS processes, governance, and performance improvement.
• Demonstrated success leading process transformation through influence, not direct ownership.
• Solid experience working with QMS and Quality leaders.
• Experience supporting regulatory inspections and audits.
• Knowledgeable about standards and regulations such as ISO 13485, ISO 14971, 21 CFR QSR Part 820, Health Canada, Brazil, China FDA, US FDA QMSR.

Skills and Competencies

• Expert understanding of QMS and product lifecycle management.
• Process design, facilitation, and change management expertise.
• Ability to influence senior stakeholders and drive alignment.
• Data‑driven approach to performance measurement and improvement.
• Excellent communication and executive presentation skills.

Key Success Indicators

• Improved process efficiency, timeliness, and effectiveness metrics.
• Reduced recurrence of systemic quality issues.
• Simplified, standardized, and well‑adopted Quality processes.
• Positive inspection and audit outcomes related to process robustness.
• Strong partnership and credibility with functional leaders and employees.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Rate: $XX - $XX

Non‑Bonus Eligible Positions: include language below.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Bonus Eligible Positions – include language below.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance‑based bonuses depending on company and individual performance