Lead Specialist, Quality, PPC Quality Engineer

GE HealthCare•Waukesha, WI

About The Position

As the Lead Quality Engineer, you will be responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Management System (QMS) practices, product specifications, and applicable standards. You will collaborate across design, design transfer, manufacturing, distribution, and service functions. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference and every difference builds a healthier world.

Requirements

Bachelor’s degree from an accredited university or college, or a minimum of 6 years of relevant work experience in medical devices or a similar regulated industry
Minimum of 3 years of experience working in a regulated industry
Strong written and verbal communication skills in English
Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and databases)

Nice To Haves

Demonstrated understanding of medical device QMS and regulatory requirements, including but not limited to FDA 21 CFR Part 820 and ISO 13485
Experience in Quality Assurance, Quality Engineering, Design Engineering, or Manufacturing Engineering within a regulated industry
Proven ability to communicate effectively across functions and organizational levels on QMS concepts, including Production and Process Controls, CAPA, Risk Management, and Product Quality
Strong collaboration, negotiation, and conflict resolution skills
Experience conducting internal audits and supporting external audits
Understanding of design change, document control, and manufacturing/process change control methodologies
Strong analytical, problem-solving, and root cause analysis skills, with demonstrated experience leading and implementing change
Ability to manage multiple priorities effectively
Strong technical aptitude, including the ability to read and interpret technical documentation and provide actionable feedback

Responsibilities

Creates a quality-focused culture by driving compliance activities across a specific product, site, or region.
Ensures quality and regulatory compliance while improving process effectiveness and efficiency through the implementation of lean processes and standard work.
Represents GE HealthCare to external agencies and champions the evolution of the quality culture, including executing and driving quality objectives, metrics, reporting, and operating mechanisms.
Serves as a best practice and quality resource; contributes to strategy and process development, and ensures delivery within the area of responsibility.
Acts as a skilled influencer, able to communicate complex messages effectively.
Collaborates with Quality teams and internal stakeholders; may lead projects with moderate risk and resource requirements.
Uses sound judgment to make decisions and solve moderately complex problems.
Applies technical expertise and data analysis to support recommendations and drive solutions.
Leads process efficiency and compliance initiatives through the development and implementation of equipment qualification and process validation activities, including: Master Validation Plans (site-level), Validation Master Plans (product- or process-specific), Detailed process flow diagrams outlining inputs, outputs, risks, and interdependencies.
Utilizes risk management tools, including but not limited to pFMEA and dFMEA.
Supports continuous product and process improvement through detailed failure analysis of nonconformances.
Investigates, develops, and implements effective, compliant solutions, including corrective and preventive actions (CAPA), remediation plans, and retrospective actions.