Lead Quality Engineer, Digital Production and Process Controls

Job Description SummaryAs the Lead Quality Engineer, Digital Production and Process Controls you be will 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 practices, product specifications and applicable standards. You will collaborate within the areas of design, design transfer, manufacturing, distribution, and service.
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.

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around digital production and process controls. This includes being responsible for the quality management system for the business and driving Quality metrics across design, design transfer, manufacturing, distribution, and service.
• Ensures quality and regulatory compliance while driving 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 which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Serves as best practice/quality resource. Contributes towards strategy, process development, and ensures delivery within area of responsibility.
• Skilled influencer, able to communicate complex messages to others. Collaborates with colleagues in Quality and internal customers. May lead projects with moderate risks and complex resource requirements.
• Uses judgment to make decisions or solve moderately complex tasks or problems. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations.
• Leads process efficiency and compliance effectiveness through the development and implementation of equipment qualification and process validation, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks, and impacts. Utilizes risk management tools including but not limited to pFMEA/dFMEA.

• Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

​Required Qualifications

• Bachelor's degree from an accredited university/college or a minimum of 8 years of relevant work experience in Medical Devices, or similar regulated industry.
• Minimum of 5 years of experience working in a regulated industry.
• Ability to communicate effectively in English (both written and oral).

• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

​Desired Characteristics

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, and Software as a Medical Device (SaMD) regulations.
• Experience in Quality Assurance, Quality Engineering, Design Engineering or Manufacturing Engineering in a regulated industry.
• Demonstrated expertise to effectively communicate within different functions and different levels of the organization around QMS concepts including Production & Process Controls, Corrective & Preventive Action (CAPA), Risk Management, Product Quality, and Cybersecurity.
• Demonstrated collaboration, negotiation, and conflict resolution skills.
• Experience performing internal audits and participating in external audits.
• Demonstrated understanding of design change, document change control and manufacturing/production process change control processes and methodologies.
• Demonstrated understanding of computerized system validation and process validation.
• Ability to demonstrate analytical, problem solving & root-cause analysis skills along with experience leading and implementing change.
• Ability to handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e., able to read & comprehend technical documentation & provide technical feedback)

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $117,040.00-$175,560.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.