Position Summary

The Quality Engineering Manager is responsible for leading the Quality Engineering department and ensuring the effective implementation, maintenance, and continuous improvement of quality engineering processes throughout the product lifecycle. This role manages a team of Quality Engineers responsible for product and process risk management, validation activities, supplier quality, component qualification, statistical analysis, complaint investigations, post-market surveillance, design history file maintenance, and support of the Corrective and Preventive Action (CAPA) system. The Quality Engineering Manager partners closely with Manufacturing, Operations, Technical Operations, Regulatory Affairs, Supply Chain, and Quality Assurance to ensure products consistently meet customer, regulatory, and company quality requirements while driving continuous improvement throughout the organization.

Job Duties/Responsibilities

• Leadership & Team Management - Lead, mentor, and develop the Quality Engineering team by setting goals, managing staffing, workload, hiring, training, performance and career development, and overseeing daily operations, while fostering a culture of quality, accountability, continuous improvement, and compliance and serving as a liaison between management and staff.
• Risk Management - Oversee product and process risk management across the lifecycle, ensuring compliant risk assessments, cross-functional reviews, and effective mitigation and documentation of identified risks.
• Validation - Govern validation activities (process, equipment, software, and test method validation), ensuring protocols and reports meet regulatory and internal quality requirements.
• Supplier Quality & Component Qualification - Lead supplier quality engineering activities, including supplier qualification, audits, performance monitoring, component qualification, first article reviews, investigations, corrective actions, and collaboration with Supply Chain to manage supplier performance and risk.
• Statistical Analysis - Promote and provide guidance on the application of statistical methods to support product quality, process capability, validation, trend analysis, sampling, and continuous improvement.
• Complaint Handling & Post-Market Surveillance - Lead complaint handling and post-market surveillance activities, including engineering support for investigations, trend analysis, risk identification, product performance monitoring, continuous improvement, and support for Medical Device Reporting (MDR) investigations.
• CAPA & Nonconformance Support - Lead engineering support for nonconformance/CAPA investigations, including root cause analysis, corrective action, quality data analysis, and implementation of systemic improvements.
• Design Quality - Oversee Design History File (DHF) maintenance and support design changes, risk assessments, verification, validation, design reviews, and design transfer activities.
• Continuous Improvement - Drive continuous improvement across product quality, manufacturing, supplier performance, and quality systems through cross-functional Lean/Six Sigma projects and KPI development and monitoring.
• Regulatory Compliance - Ensure Quality Engineering processes comply with FDA QMSR, ISO 13485, MDSAP, ISO 14971, and other applicable regulations, and support internal, external, supplier audits, and regulatory inspections.
• Supervisory Responsibilities - Oversee daily team operations, including hiring, training, performance management, task assignment, communication, feedback, and employee relations, while serving as a liaison between management and staff to ensure productivity and a positive work environment.
• Other - Embodies the Company’s purpose and shared values to foster a positive and productive team culture, complies with Company policies and procedures, accesses employee and/or patient PHI and ePHI only as required for job-related duties, and performs other duties as assigned.

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, or related technical discipline required.
• Master's degree preferred.
• Minimum of 8 years of progressive quality engineering experience in a regulated manufacturing environment.
• Minimum of 3 years of leadership or supervisory experience preferred.
• Medical device industry experience strongly preferred. ASQ Certified Quality Engineer (CQE) preferred
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred
• Six Sigma Green Belt or Black Belt preferred
• Certified Reliability Engineer (CRE) or equivalent quality certification preferred
• Demonstrated experience with validation, risk management, supplier quality, and quality systems.
• Strong understanding of and proficiency Quality Management Systems (eQMS) and regulatory requirements.
• Working knowledge of FDA Quality Management System regulations, ISO 13485, MDSAP, and ISO 14971 risk management principles.
• Experience with Design Controls and Design History File management.
• Thorough understanding of process validation methodologies and statistical analysis.
• Knowledge of complaint handling, post-market surveillance, and supplier quality management.
• Strong analytical and problem-solving abilities and organizational and decision-making skills.
• Excellent written and verbal communication skills.
• Ability to lead cross-functional teams and manage multiple complex projects.
• Proficiency with Microsoft office programs and the Internet.
• Willingness to work a flexible schedule and to travel as needed for work. 
• Satisfactorily pass comprehensive background screening and drug screening (if applicable to position).

Physical Demands/Working Conditions

• Typical work environment for a professional office with work also conducted in a manufacturing environment (supply room, laboratory, and/or clean room).
• Typically a stationary role with frequent moving from place to place.
• Constant use of a computer, keyboard, mouse, monitor and other office equipment.
• Occasionally picks up, carries, and moves items up to 50 lbs.
• Potential exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Some evening and weekend work depending on workload.
• Some overnight travel may be required for work, events, and training.