Role Overview:

Purpose: The Regional End to End Quality Lead serves as the primary leader to drive resolution to all customer related quality concerns in the region. This individual will have governance authority for quality operations across the region, driving strategic oversight and decision-making to ensure zero-defect delivery, regulatory excellence, and continuous customer satisfaction improvement.

Scope: End-to-end accountability for quality issue resolution and  governance and problem solution spanning product development, manufacturing, distribution, and post-market surveillance across all regional business units and functional areas.

Key Focus: Establish and enforce governance frameworks that improve External Parts Per Million (EPPM), eliminate defects at source, and embed quality decision-making authority at every process node working closely with Process Excellence team, functional leaders to establish containment and corrective actions, standards ad processes for each of the EDTR pillars – Manufacturing, Supply Chain, Engineering, and Field and Install.

Governance & Decision Making Authority               

Authority Level: Empowered Decision-Maker

• Full authority to halt production, reject product releases, and escalate systemic quality issues directly to executive leadership without intermediate approval

  • Lead and drive actions to contain quality issues and corrective actions. Provide updates to all stakeholders including Presidents.

  • Close the loop by identifying gaps in the current QMS system and involving the process excellence team and functional leaders - drive CI where it matters.

Decision Rights: Strategic Quality Decisions

• Final approval authority on quality risk assessments and mitigation strategies

• Authority to allocate quality resources and budget across regional operations

• Decision-making power over quality system changes, deviations, and CAPA prioritization

• Veto authority on process changes that introduce quality risk

Accountability: Quality Performance Ownership

• Direct accountability for regional EEPm metrics, customer complaints, regulatory inspection outcomes, and defect rates with executive-level reporting responsibility

Key Responsibilities:

1. Quality Governance Framework 

• Design and implement regional quality governance structure with clear decision-making protocols

• Define escalation pathways and decision rights matrix across quality organization

• Create governance dashboards for real-time quality performance visibility

2. Risk Management & Prevention   

• Lead enterprise risk assessment using FMEA, HACCP, and predictive analytics

• Govern risk mitigation strategies with accountability for risk closure

• Implement early warning systems for quality degradation detection

• Drive root cause analysis and systemic CAPA for zero recurrence

3. Regulatory Compliance Leadership         

• Ensure regional compliance with FDA, EMA, ISO 13485, and applicable regulations

• Authority to implement compliance strategies and allocate resources

• Own regulatory inspection readiness and response coordination

• Drive continuous compliance monitoring and gap remediation

4. Quality Culture & Capability         

• Build quality competency framework with role-based training requirements

• Champion quality-first culture with visible executive sponsorship

• Drive employee engagement in quality improvement initiatives

• Establish quality recognition programs tied to EEPm and defect reduction

5. Customer & Stakeholder Management 

• Own customer quality relationships with direct escalation authority

• Drive customer satisfaction improvement through Voice of Customer programs

• Lead quality business reviews with key accounts and stakeholders

• Manage external audit relationships and certification processes

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, or related field.

• Minimum of 10-15 years of experience in quality management or a related field, preferably in a manufacturing environment.

• Proven track record of resolving complex quality issues and driving customer satisfaction.

• Strong analytical skills with the ability to interpret data and trends.

• Excellent communication and interpersonal skills to effectively engage with customers and internal teams.

• Experience with Lean and Six Sigma methodologies and tools.

• Strong ability to influence cross-functional teams and manage complex issues.

• Willingness to travel as required to support customer needs and quality assessments.