Lead Quality Assurance Engineer

Quality Assurance Lead Engineer

The Quality Assurance Lead Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The QA Lead Engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and service. The QA Lead Engineer may lead programs and initiatives and/or have responsibility for coaching more junior engineers. This position is on-site in El Paso, TX.

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.

Key Responsibilities Include:

• Responsible for ensuring quality and regulatory compliance in accordance with documented procedures.
• Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
• Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans.
• Perform detailed failure analysis for non-conformances. Develops and implements effective and compliant solutions for product or process corrections and for corrective and preventive actions (CAPA Program).
• Develops risk management tools and aids for use by the organization in accordance with documented procedures. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
• Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

Required Qualifications:

• Bachelors Degree in an engineering or technical discipline (or non-technical degree with 4 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
• 3+ years of quality experience.
• Knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
• Effectively communicate within all levels of the organization.
• Collaboration, negotiation & conflict resolution skills.

Preferred Qualifications:

• Understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Change agent with energy, passion & enthusiasm to drive change.
• Analytical, problem solving & root-cause analysis skills.
• Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment.
• Bilingual (English / Spanish)

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).