Fresenius Medical Care · 5 hours ago
Director Quality Process Excellence & Transformation QMS North America
Lawrence, MA
Full-time
Onsite
Director/Executive
$130K/yr - $220K/yr
10+ years expFresenius Medical Care is seeking a Director of Quality Process Excellence & Transformation to lead process improvements and ensure compliance across QMS North America. This role involves driving quality process strategies, collaborating with various stakeholders, and leading initiatives to enhance operational excellence and continuous improvement.
BiotechnologyHealth CareMedical Device
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
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
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
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
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
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
Qualification
Required
Bachelor's degree required (Science, Engineering, or related field)
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
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
Preferred
Professional quality discipline certification is a plus (e.g., CQE, CQA)
Master's degree preferred
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off
Parental leave
Potential for performance-based bonuses depending on company and individual performance
Company
Fresenius Medical Care
Fresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases.
10001+ employees
H1B Sponsorship
Fresenius Medical Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (14)
2022 (18)
2021 (10)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
$758.43M2025-11-17Post Ipo Debt· $579.5M
2025-07-21Post Ipo Equity· $4.86M
2020-02-25Post Ipo Equity· $6.07M
Leadership Team
Helen Giza
Chief Executive Officer
Joseph Turk
CEO of Care Enablement and Member of the Management Board of Fresenius Medical Care
Recent News
2025-11-19
Company data provided by crunchbase