QA Leader Regional Quality PDx, USA

Quality Assurance Specialist

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements for medical devices and pharmaceutical products distributed by PDx. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Roles and Responsibilities :

• Creates a Quality culture by driving compliance activities around a Life Sciences product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. 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.
• Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).
• Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and / or other local or international quality systems requirements.
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy / strategy.
• 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.
• 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.

Required Qualifications :

Desired Characteristics :

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.

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).