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, 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.
$130,000 - $220,000
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.
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
