GE HealthCare QA Specialist 

United States, Wisconsin 

67382357

Responsibilities :

• 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 quality

Qualifications :

• 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 packages

Desired 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 skills

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.