Fresenius Medical Care

Director, Quality Process Excellence and Transformation, QMS

Fresenius Medical Care

full-time

Posted on:

Location Type: Office

Location: Waltham • Massachusetts • United States

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Salary

💰 $130,000 - $220,000 per year

Job Level

Lead

About the role

  • 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.

Requirements

  • 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.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
QMS processesprocess improvementLean methodologySix SigmaCAPA managementregulatory complianceperformance improvementmanagement control frameworksdata analyticsprocess optimization
Soft Skills
collaborationinfluencementoringstakeholder engagementcommunicationcross-functional alignmenttrusted advisoreducation and trainingchange managementdecision-making
Certifications
ISO 13485ISO 1497121 CFR QSR Part 820