QA Specialist

Job Description SummaryThis position within the QA department of the GE HealthCare Electric Avenue design and manufacturing site supports product release of medical devices through the review of key documentation and facilitates continuous improvement of manufacturing of medical devices. This position will also lead the quality management system to ensure internal and external compliance and customer satisfaction. This is an on-site role.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 DescriptionResponsibilities :- Review production documentation and assist with batch release procedures which requires repetitive lifting (approximately 20 lbs), bending, and/or twisting- Support the timely release of product to market- Liaise with Operations personnel to ensure regulatory and quality requirements are met and understood during routine operations- Responding to routine quality related queries from other departments- Support the site CAPA system through record ownership and QA review- Own QMS training at the site and all associated metrics- Manage (develop, maintain, and improve) the site quality management system and associated processes at the site for compliance and efficiency, including the creation and maintenance of QMS work instructions- Strong support of the internal audit program and all external audits, including representing GE HealthCare to external regulatory bodies- Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP.- Collaborates with all other departments to ensure quality compliance and product qualityQualifications :- Bachelor's degree from an accredited university or college in technical field or equivalent experience; or Associate degree and 3 years or more of experience in a medical device or regulated industry; or 5 years or more of experience in a medical device or regulated industry- Knowledge of relevant Electronic Management Systems transactions and proficiency with Excel / Word packagesDesired Characteristics :- 2+ years experience in medical device field (or similar regulated industry)- Detail oriented and highly organized- Strong oral and written communication skills- Demonstrated ability to analyze, resolve, and document problems- Experience developing and tracking quality metrics- Familiar with Continuous Improvement methodologies, including Six Sigma and/or Lean methodologies- Established project management skills- Excellent interpersonal skillsWe 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-MC2Additional InformationGE 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