Job Description SummaryThe Quality Assurance Leader is responsible for the zone’s compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system, controls and continuous improvement and establishing best practice standards to assure product safety and quality.

Job Description

Description:

The Quality Assurance Leader is responsible for the zone’s compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system, controls and continuous improvement and establishing best practice standards to assure product safety and quality.

Key responsibilities include:

Participate in the development and maintenance of the region Quality Management System (QMS) and relevant processes to assure product quality and safety.Ensure company procedures and proper documentation practices are followed per GE Healthcare QMS requirementsAttend region/zone QMS and metrics reviews with service and business management functionsCoach and mentor functional teams on the development, maintenance and implementation of local procedures (if any)Provide advice & counsel the business managers in the zone with QMS related processesAssist the Quality Assurance Site Manager (when applicable) in preparation for internal/external audits and implementation of corrective actions to address non-conformities.Work closely with other functional areas (e.g. Marketing, Engineering, Service) to ensure compliance to applicable regulationsLead and support continuous improvement activities assigned, which may include such areas as: ISO standards compliance, Risk management, and metrics development/implementation.

Qualifications:

Bachelor's degree in Engineering, Medical Device Technology or Scientific Field Experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry Knowledge and experience with ISO9001 and 13485, and/or other international quality systems requirementsProven track record in performing external and internal audits preferred.  Ability to read, analyze and interpret business plans, technical procedures and governmental regulations Strong computer skillsAbility to communicate fluently in EnglishFront line operational responsibility in Field Service but also support technology transfer projects, guide/support sourcing for compliant purchases and support supplier quality initiatives where necessary

​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.

Behaviors

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.

Total Rewards

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