Sustaining Quality Engineering Team Lead

Job Summary

The Sustaining Quality Engineering Team Leader is responsible for leading, planning, coordinating, and executing quality operations activities and NPI projects aimed at improving quality and driving strategic initiatives within the Quality function. This role ensures compliance with customer requirements, oversees quality operations planning, and collaborates across internal functions to support quality‑related matters. The position also manages risk processes for medical devices, drives cost reduction and process improvement initiatives using Lean and Six Sigma methodologies, and leads a team of quality professionals to meet departmental and organizational goals.

• Bachelor's degree in Engineering or a related science/technical/business field.
• Proven experience (5+ years) in quality management, operations, or engineering within the medical device industry.
• Advanced proficiency in English and Spanish.
• Strong expertise in holistic quality engineering structures and associated tools/techniques such as Six Sigma, FMEA, Risk Analysis, Component Qualification, Control Plans, Testing/Inspection Programs, and Verification & Validation activities.
• Understanding of project management techniques and approaches.
• Knowledge of Medical Device Regulatory Requirements, including ISO 13485, European Regulations, 21 CFR Part 820, and Good Manufacturing Practices (GMP).
• Solid leadership skills with the ability to guide and mentor others.

• Lead, plan, coordinate, and execute quality operations and projects focused on quality improvement and strategic initiatives.
• Participate in change management processes to ensure products/services meet customer requirements.
• Act as the quality operations representative in human resource management.
• Establish robust quality operations plans to achieve zero defects and lead quality initiatives for large‑scale product quality improvement.
• Review and improve quality‑related processes and procedures as needed.
• Collaborate with internal functions such as Sales, Marketing, Engineering, Supply Chain, and Manufacturing to support quality matters.
• Provide resources and expertise to design functions for effective delivery of medical device projects in compliance with applicable regulations.
• Use analytical tools to identify improvement opportunities and support implementation of product and process improvements.
• Develop, maintain, and implement medical device risk management processes to ensure acceptable risk levels and regulatory compliance.
• Work with business leaders to identify cost reduction or revenue‑generating approaches, validate opportunities, and improve decision‑making frameworks.
• Plan and implement multiple cost reduction, cost avoidance, productivity, and process improvement projects across the organization using Lean and Six Sigma methodologies.
• Recruit, develop, motivate, and manage the QE team to meet departmental and company needs.
• Support progress toward key initiatives and objectives for direct reports.
• Manage quality budget lines under leadership.
• Act as management representative for quality system processes, reporting performance to senior management, promoting regulatory and customer awareness, organizing audits (internal and external), ensuring ISO certification and surveillance, managing supplier audits, and supporting FDA inspections.