GE HEALTHCARE-posted about 18 hours ago
Full-time • Mid Level
5,001-10,000 employees

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. 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. 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.

  • Creates a Quality culture by driving compliance activities around a specific product, site or region.
  • 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.
  • 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.
  • Bachelor's Degree or a minimum of 9 years work experience.
  • Minimum of 5 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 project teams.
  • Demonstrated understanding or aptitude as it regards to primarily 21CFR212 as well as secondarily 21CFR211.
  • Ability to travel domestically up to 40%.
  • 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.
  • Desired: Master's Degree or PhD in Engineering or Science or Pharmacy.
  • 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 & in-depth understanding of site level products & related processes
  • Demonstrated expertise 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.
  • GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service