Job Description SummaryAs the Sr. Quality Assurance Manager, you will be responsible for ensuring Pharmaceutical Diagnostics (PDx) regional quality and regulatory compliance of a PDx MEACAT region, including direct and indirect markets, while driving process effectiveness and efficiency. You will represent GE Healthcare PDx to external agencies and champions the evolution of the quality culture for the region.

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 DescriptionRoles and ResponsibilitiesComply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.Quality Management System (Good manufacturing practices and Good Distribution Practices) – implement and maintain a QMS for distribution and supporting activities, including deviations, investigations, complaints, change controls, and corrective and preventive actions.Management of outsourced activities and suppliers/vendors, including distributors and wholesalers.Complete all planned Quality & Compliance training within the defined deadlines.Identify and report any quality or compliance concerns and take immediate corrective action as required.Identify and ensure timely closure of corrective and preventive actions for the region.Participate and represent the Region in regional staff meetings/events.Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements.Timely communication of all quality concerns, initiatives, and information to the site Management team.Meet specific quality metrics and/or milestones as defined in annual business objectives.Operate regional inspection and internal audit programs and manages follow up activities to close Nonconformities.Operate supplier audit program and timely closure of audit actions (for Direct and Indirect markets).Management of illicit practice incidents and ensure proper escalations.

Required QualificationsSignificant experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 10 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment).Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry. Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities.Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.Proven track record in performing external and internal audits. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations. Effective report, business correspondence and procedure writing skills.   Good problem identification, multivariable analysis and creative resolution aptitude.Proven process development and project management skills.Strong computer skills.Ability to communicate using English, and French OR Arabic.

Desired CharacteristicsDemonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.Experience in a global, matrixed organization structure.Professional certification as a Lead Auditor. Six Sigma training and/or certificationTeam player with a global mindset.Strong Change Acceleration skills.   Experience in building a Quality System from ground up. 

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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.

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Additional Information

Relocation Assistance Provided: No