Principal Business Excellence Quality Engineer

Position Summary

The Principal Business Excellence Quality Engineer is a key leadership role responsible for driving business process improvements, operational excellence, and quality initiatives across the organization. This position will leverage expertise in quality engineering, process improvement methodologies, and data-driven decision-making to optimize business performance, ensure regulatory compliance, and enhance overall efficiency.

The role requires close collaboration with cross-functional teams, a strong understanding of quality systems, and the ability to identify and execute strategies that align with organizational goals.

Key Responsibilities

• Lead Business Excellence initiatives by identifying opportunities for process optimization and operational efficiency across the organization.
• Utilize Lean, Six Sigma, and other process improvement tools to drive improvements, reduce waste, and enhance productivity.
• Lead cross-functional teams to execute process improvement projects, ensuring alignment with business objectives and measurable outcomes.
• Develop and implement Key Performance Indicators (KPIs) and metrics to monitor and measure process performance.
• Facilitate workshops, training, and process mapping exercises to drive a culture of continuous improvement.

• Ensure alignment and integration of quality system processes with business excellence initiatives.
• Support compliance with ISO 13485, FDA QSR, and other relevant regulatory standards by enhancing processes and systems.
• Evaluate current quality processes and systems to identify and implement improvements that enhance efficiency and compliance.
• Collaborate with Quality, Operations, and R&D teams to ensure processes meet regulatory, design, and manufacturing requirements.

• Lead risk management efforts, including facilitation of Process Failure Modes and Effects Analysis (PFMEA) and Hazard Analysis to identify and mitigate potential risks.
• Drive the integration of risk management strategies into product and process development.

• Analyze complex data sets using statistical tools (e.g., hypothesis testing, DOE, regression, SPC) to identify trends, root causes, and opportunities for improvement.
• Provide data-driven insights and recommendations to leadership for improving business and quality system performance.
• Lead efforts to automate reporting processes for real-time monitoring and improved decision-making.

• Collaborate with leadership and cross-functional teams (e.g., Quality, Operations, Supply Chain, R&D) to ensure alignment of business excellence initiatives with organizational goals.
• Mentor and train teams on process improvement methodologies, tools, and best practices.
• Serve as a change agent to foster a culture of quality, continuous improvement, and operational excellence.

• Partner with executive leadership to define and execute Business Excellence strategies that drive long-term organizational success.
• Develop roadmaps for implementing business excellence projects, including timelines, resources, and success criteria.
• Monitor and communicate progress, ensuring accountability and alignment with company priorities.

Required Qualifications

• Bachelor's degree in Engineering, Business, Quality Management, or related technical field. Master's degree preferred.
• 8+ years of experience in Quality Engineering, Operational Excellence, or Process Improvement roles within a regulated industry (e.g., medical devices, pharmaceuticals).
• Proven expertise in Lean Six Sigma methodologies (Black Belt certification preferred).
• Strong understanding of ISO 13485, FDA QSR, and other regulatory requirements.
• Demonstrated experience leading cross-functional process improvement projects with measurable outcomes.
• Proficiency in statistical analysis tools (e.g., Minitab, JMP, or equivalent) and data-driven decision-making techniques.
• Excellent project management, leadership, and facilitation skills.
• Strong communication, collaboration, and problem-solving abilities.

Preferred Qualifications

• Certified Six Sigma Black Belt or Master Black Belt.
• Experience with ERP, QMS, and process automation tools.
• Knowledge of Design for Six Sigma (DFSS) or similar methodologies.

Benefits

• Competitive salary and performance-based bonuses
• Comprehensive health, dental, and vision benefits
• 401(k) with company match
• Opportunities for professional development and career growth
• Dynamic, innovative, and collaborative work environment