Job Abstract

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities, supporting the total quality management system, and site trending to achieve Quality objectives.
• Facilitates the CAPA input processes of Nonconformance, Investigations & Concessions / Deviations.
• Leads execution of the CAPA system employing project management, lean methodologies, problem solving, and works cross functionally to ensure robust quality decisions and CAPA timeliness.
• Facilitates Product Holds when deemed necessary from CAPA, Nonconformances or Investigations.
• Leads others to find creative solutions to address complex problems.
• Ensures site audit readiness and hosts the Quality System audits, representing GE HealthCare to external agencies
• Leads the internal audit program, ensuring compliance with the GEHC QMS, all applicable regulations and standards, with escalation to CAPA as applicable.
• Support achievement of site Quality objectives and QMS systems
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
• A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.

Required Qualifications

• Bachelor's Degree or a minimum of 10 years work experience.
• Minimum of 5 years working in regulated medical device or pharmaceutical industry.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including, but not limited to FDA CFR 21 820 and ISO 13485.
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally)
• Ability to communicate effectively in English (both written and oral).

Desired Characteristics

• Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry, or experience in design engineering or manufacturing engineering in the medical device field.
• Demonstrated knowledge of Quality Management System tools & continuous improvement methodologies
• Proven ability to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Experience performing internal and external audits.
• Demonstrated ability to make risk-based decisions in a compliant manner.
• Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Exceptional analytical, problem solving & root-cause analysis skills.
• Strong interpersonal skills demonstrating a culture of Quality .
• Ability to multi-task & handle tasks with competing priorities effectively.

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

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.