Job Description Summary

Managing, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

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

• Executes against GE HealthCare's Central Quality & Regulatory Audit program. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; and ensuring audit strategy is executed to current industry practices and regulatory expectations.
• Supports GE HealthCare’s Health / Competent Authority audits. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
• Supports GE HealthCare’s Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues. Regularly advises management in Central Quality.
• Requires specialized depth and/or breadth of expertise within a quality or regulatory discipline and ability to influence the development of strategy within own area, including participation in policy formulation.
• Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view.
• Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives.
• Uses high level of judgment to make decisions and handle complex tasks or problems. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

Required Qualifications

• Qualified Lead Auditor with active certification.
• Master’s Degree and a minimum of 7 years’ experience in the medical device industry; OR Bachelor's Degree and a minimum of 9 years’ experience in the medical device industry.
• Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly).
• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Experience with auditing to ISO 17025, reviewing sterilization validations, protocols, SOPs, reports, and knowledge of ISO 10993 series, ISO 17664, ISO 11135, ISO 11137, data integrity, sample handling, and laboratory equipment including IQ, OQ, PQ, GLP, and GMP, as well as terminal sterilization methods.

Desired Characteristics

• Prior notified body or health authority experience a plus.
• ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). Software Quality Engineer (CSQE) strongly preferred.
• Design controls, design verification, and validation activities.
• Production and process controls.
• Class III US FDA PMA Device requirements.
• CAPA, complaints, and risk management.
• Understanding of product quality improvement using tools such as Six Sigma, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-resolution skills.
• Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
• Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs.
• Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions.
• Strong oral and written communication skills in English.
• Integrity: Accepting and adhering to high ethical, moral