Lead Quality Engineer

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive).

Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

Job Description

Roles and Responsibilities

Creates a Quality culture by driving compliance activities around a specific 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.

• Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy / strategy. Basic knowledge of related job disciplines.
• Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements.

Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.

Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results.

The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).

Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems.

Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Required Qualifications

• Bachelor's Degree or a minimum of 6 years work experience.
• Minimum of 3 years working in a regulated medical device or pharmaceutical industry.
• Ability to communicate effectively in English (both written and oral).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
• Experience managing projects.
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• CAPA experience
• Internal Audit Experience

LI-MC2

Additional Information

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).

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.

Relocation Assistance Provided : No