Quality Engineering Manager

GT Medical Technologies, Inc.•Richland, WA

4h•$115,000 - $135,000•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, or related technical discipline required.
Minimum of 8 years of progressive quality engineering experience in a regulated manufacturing environment.
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).

Nice To Haves

Master's degree preferred.
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

Responsibilities

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.
Oversee product and process risk management across the lifecycle, ensuring compliant risk assessments, cross-functional reviews, and effective mitigation and documentation of identified risks.
Govern validation activities (process, equipment, software, and test method validation), ensuring protocols and reports meet regulatory and internal quality requirements.
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.
Promote and provide guidance on the application of statistical methods to support product quality, process capability, validation, trend analysis, sampling, and continuous improvement.
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.
Lead engineering support for nonconformance/CAPA investigations, including root cause analysis, corrective action, quality data analysis, and implementation of systemic improvements.
Oversee Design History File (DHF) maintenance and support design changes, risk assessments, verification, validation, design reviews, and design transfer activities.
Drive continuous improvement across product quality, manufacturing, supplier performance, and quality systems through cross-functional Lean/Six Sigma projects and KPI development and monitoring.
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.
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.
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.