**Job Description Summary** This position provides process support in accordance with documented global & local QMS procedures & practices. The Manager, Quality, CAPA Leader develops the strategy for the site CAPA program to meet compliance requirements and is responsible for the development, implementation and improvement of QA practices. The role may involve work in CAPA, QMS processes, design, design transfer, manufacturing, distribution, and service. 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** **Responsibilities** + CAPA Leader leads quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility + Executes overall CAPA Program and oversees the CAPA Review Board pertaining to closure of CAPA System Activities + Leads site trending and metrics reporting and applies as inputs to the CAPA process + Develops, implements, and continuously improves process effectiveness and efficiency at the site. + Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc. + Ensures process efficiency and compliance with the site's quality plan. + Identifies and influences continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program) + Utilizes and shapes the risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process. + Interfaces with site leadership on various initiatives.Leverages metrics and data to assist in shaping the strategy and focus for the site. + The Senior Quality Engineer that coaches junior Quality Engineers. **Qualifications** + Bachelor's Degree or a minimum of 10 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 to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. **Desired Skills​** + Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead projects/initiatives. Established project management skills + 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 QMS relevant concepts + Demonstrated collaboration & conflict resolution skills + Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance + Demonstrated understanding of product development lifecycles, design change anddocument change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S) + Experience leading and implementing change + Experience performing internal and external audits + Exceptional analytical, problem solving & root-cause analysis skills + Ability to prioritize and handle tasks with competing priorities effectively + Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators​ 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. \#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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) . 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