Lead Specialist, Quality Management Systems, Digital

Job Description SummaryThis position will support the Chicago Quality Organization by implementing and upholding GEHC Quality Management System (QMS) requirements and procedures for GEHC Digital products. You will work with cross functional teams to provide guidance and ensure compliance with QMS requirement activities to ensure patient safety, reduce regulatory risk, and enable commercial delivery of GE HealthCare Digital products.
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

• Foster a Quality culture by driving compliance to global and local policies, procedures and work instructions included in the Chicago Site Quality Plan

• Support the Chicago Non-conforming (NC), Investigation & CAPA processes by providing coaching on conducting and documenting root cause analysis, product/process impact & risk assessments, defining corrections, corrective & preventive actions, and effectiveness checks

• Collaborates with the implementation and monitoring of global and local QMS documentation changes as well as the Chicago site Training program

• Conducts internal audits of the QMS to ensure high level of compliance

• Supports external audits from regulators by preparing information, assisting during the audit execution and follow up of post audit activities

• Performs a broad variety of QMS & compliance tasks as result of continual improvement initiatives or as assigned by supervisor

• Champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms for QMS processes

• Support the Chicago Quality team by following up on QMS related projects deliverables

• Explains information and influences team members to consensus around total quality and continuous improvement.

• Employs risk based thinking approach across QMS processes.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience) in computer, science or engineering field.

• Minimum of 2 years of work experience in quality assurance or quality engineering in a medical device organization.

• Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.

Desired Characteristics

• Good understanding and knowledge of local and global Medical Device QMS regulations and standards such as but not limited to FDA 21 CFR 820, EN ISO 13485, EU MDR.
• Experience with Software as Medical Device (SaMD) is a plus.
• Demonstrated expertise to effectively communicate within all levels of an organization around concepts like NC, Corrective & Preventive Action (CAPA), Personnel training, Document & Record control and product quality.
• Knowledge of Risk Management standards/practices.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Strong time management, prioritization and organization skills.

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.

For U.S. based positions only, the pay range for this position is $93,280.00-$139,920.00 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.

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.