Sr Quality Process Excellence Engineer

The position serves as a process change leader and liaison, 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.

Principal Duties and Responsibilities

• Drive process improvements and changes by working collaboratively with all stakeholders while driving simplicity in QMS and its processes and systems.
• Breakdown complex and complicated processes and systems and reconnect to make it simple and effective while maintaining its compliance requirements.
• 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.
• Provide solutions to stakeholders regarding processes and systems to drive right changes.
• 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

• Carry out process and system changes and improvements.
• 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.

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.
• Training in lean and/or six sigma practices a plus.

Experience and Required Skills

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