Sr Manager, Process & Quality Engineering

GE HealthCare•Florence, SC

7d•Onsite

About The Position

The Senior Manager, Process & Quality Engineering leads an integrated manufacturing engineering and product quality team to ensure safe, reliable, compliant, and efficient production operations. This role oversees process engineering, validation, equipment readiness, product quality, project management, and continuous improvement while providing direct support to daily operations.

Requirements

Bachelor’s degree in Engineering or a related field.
10+ years of progressive experience in manufacturing engineering, operations, or product quality.
Experience in roles such as Production Supervisor, Department Manager, Process Control Engineer, Facilities Manager, or Plant/Project Engineer.
5+ years of leadership experience.
Strong technical expertise in Lean, Six Sigma, DOE, SPC, PFMEA, CAPA, and validation.
Experience with ISO, GMP, and QMS standards.
Demonstrated success improving manufacturing processes.

Nice To Haves

Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems.
Demonstrated ability to lead programs / projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Master’s degree in Engineering or Operations.
Lean Six Sigma Green Belt or Black Belt certification.

Responsibilities

Lead engineering project and portfolio management, including prioritization, resource planning, budgeting, and cross‑functional coordination.
Manage complex engineering and capital projects, ensuring scope, cost, schedule, and quality objectives are met.
Develop and execute the site’s manufacturing and product quality strategy aligned with business and operational goals.
Serve as a technical leader, promoting best practices across engineering, manufacturing, and quality, and influencing cross‑functional teams to drive alignment and execution.
Maintain a safe and compliant work environment in accordance with OSHA requirements and internal policies.
Lead the development, qualification, and validation of manufacturing processes and equipment (IQ/OQ/PQ).
Identify, design, and implement process improvements to enhance quality, throughput, reliability, and cost efficiency.
Support technology transfers, scale‑up activities, and process readiness for full-scale production.
Lead the standardization of engineering procedures, validation methodologies, and process controls.
Investigate quality issues impacting product performance, reliability, or compliance, and implement corrective and preventive measures to prevent recurrence.
Lead process‑related failure analysis, RCA, CAPA, and PFMEA to systematically address process deviations and risks.
Monitor and interpret key quality metrics; drive improvements in process capability and product performance.
Validate, maintain, and improve production test systems, inspection methods, and quality control processes.
Drive continuous improvement in production processes by implementing Lean and Six Sigma methodologies, leading Kaizen events, eliminating waste, reducing variability, and optimizing workflow efficiency.
Champion operational excellence initiatives focused on improving OEE, reducing cycle time, enhancing equipment reliability, and strengthening overall process robustness.
Identify, prioritize, and lead cross‑functional improvement projects to enhance product quality, reduce scrap/rework, and improve process stability.
Hire, coach, and develop team members; set goals, assess performance, and build talent capabilities.
Prepare clear, concise reports on engineering initiatives, quality performance, and project status; communicate complex technical issues effectively to leadership.