PURPOSE AND SCOPE:

The Director, Quality Process Excellence & Transformation 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 Director serves as a strategic advisor, liaison, and change leader, 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 CAPA management, North America (NA) QMS activities, audit and inspection preparations, international QMS 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 leaders, employees, and all stakeholders.
• 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.
• 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

• 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.

CAPA Management Process Excellence

• Partner with local and global CAPA teams, Quality teams, and operational leaders to evaluate current-state CAPA processes and identify opportunities for improvement to ensure they are efficient, risk-based, and effective.
• Participate in identifying best practices for overall CAPA management.
• Define and monitor CAPA process performance in collaboration with functional owners.
• Facilitate cross-functional forums to address systemic CAPA issues and recurring trends.
• Engage in and support regulatory inspection readiness.

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.

EXPERIENCE AND REQUIRED SKILLS:  

• 10+ years of experience in Quality, Quality Systems, or Process Improvement in regulated industries.
• Deep experience with QMS processes, governance, and performance improvement.
• Demonstrated success leading process transformation through influence, not direct ownership.
• Strong 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.

Hourly Rate: $00.00 - $00.00

Non-Bonus Eligible Positions: include language below.
31Benefit 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.

PURPOSE AND SCOPE:

Acts as a facilitator and implementer of Business Process Improvement and Operational Excellence deployment, at the direction of the organizational VP or SVP. The focus will be to develop, roll-out, and implement Operational Excellence programs for Fresenius Medical Care (FMC) while being responsible for driving continuous improvement in productivity, cost, cycle time, efficiency, and quality throughout operations using Lean Six Sigma methodologies (Team Empowerment, Kaizen & Lean methodologies; Six Sigma DMAIC and DMADOV methodologies; etc.) and various Lean Six Sigma DFSS tools and techniques, where appropriate. Promotes a continuous learning environment to ensure ongoing training and development of teams  in the principles, techniques and methodologies of Lean/Six-Sigma. Supports FMC mission, vision, core values and customer service philosophy.  Adheres to the FMC Compliance Program, including following all regulatory and FMC policy requirements.

 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Executes an optimal roll-out approach for Lean Six Sigma deployment as defined by department VP or SVP. Implements and adheres to both short and long-term (6 months- 3 years) strategies and implementation plans that will allow FMC to best adopt the program and Lean Six Sigma culture for sustained and long-term benefit.
• Works with sub-department heads to develop and implement performance metrics for core work processes and implements continuous improvement performance targets.
• Tracks and validates all improvements and dollar savings (P&L, balance sheet, cost avoidance) attributed to the Lean Six Sigma program.
• Trains and sustains the workforce on specific aspects of Lean/Six Sigma. Supports OpEx team and development of training materials, trains business teams on the use of Lean Six Sigma tools, facilitates project teams.
• Participates in regular progress meetings and toll-gate reviews and ensures the continuous improvement process progresses within the targeted timelines.  
• Fosters a sense of urgency and champions radical change that pushes for continuous improvement with a focus on improving efficiency, quality and driving down costs.
• Assists in development and implementation of a communication plan to foster the Lean Six Sigma environment and culture.
• Works on abstract problems across functional areas of the business. Identifies and evaluates issues through assessment of intangible variables.
• Interacts internally and externally with executive level management.
• Uses advanced skills to contribute to the development of company objectives and principles. 
• Works as part of a team to determine methods and procedures on new or special assignments. Assembles and directs cross functional/cross site project team(s), including information compilation and information flow.
• Exercises advanced technical competence in Lean Six Sigma and demonstrates an understanding of the underlying principles. Demonstrates a data & process mindset, statistically verifies improvements and provides theoretical training behind statistics along with practical/pragmatic examples of its use in various functions.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Other duties as assigned.

 

 

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

 

 

 

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Up to 50% Travel

 

SUPERVISION:

• May be responsible for the direct supervision of various levels of Operational Excellence staff.

 

 

EDUCATION:

• Bachelor's Degree in Engineering (or equivalent) required, however, a combination of experience and/or education will be taken into consideration.
• Lean/Six Sigma Green or Black Belt certified. Master Black Belt Certification is Preferred or will be sought on the job.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 6-10 years of relevant experience plus experience as a manager for 3-5 years.
• Lean Six Sigma experience required.
• Strong business acumen. Prior experience in a large distributed workforce within a matrixed environment.
• Facilitation & Change Management leadership skills/experience required, preferably certified as Change/Facilitation leader.
• Proficient in Microsoft Excel, Project and PowerPoint; and statistical software.
• Excellent planning, organization, analysis, and problem solving skills.
• Proven leadership ability, excellent facilitation skills.
• Excellent written and oral communication skills. Influences and motivates teams.
• Ability to read and interpret comprehensive and intricate research documents.
• Ability to write scientific reports and technical correspondence.
• Ability to work with executives and communicate abstract concepts.
• Ability to present to a high level of the organization and groups outside of the organization.

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.

Hourly Rate: $00.00 - $00.00

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.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors