Quality Engineer I at Abbott in St Paul, MN

Summary: Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a Quality Engineer I, you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system/services support. Responsibilities: - Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements - Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements - Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues - Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues - Design and conduct experiments for process optimization and/or improvement - Appropriately document experiment plans and results, including protocol writing and reports - Lead process control and monitoring of CTQ parameters and specifications - Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) - Lead the investigation, resolution and prevention of product and process nonconformances - Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) - Lead in the completion and maintenance of risk analysis - Work with design engineering in the completion of product verification and validation Required Qualifications: - Bachelor's degree in engineering or Technical Field or an equivalent combination of education and work experience - 0-2 years Engineering experience - Ability to work in a highly matrixed and geographically diverse business environment - Ability to work within a team and as an individual contributor in a fast-paced, changing environment - Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization - Multitasks, prioritizes, and meets deadlines in timely manner - Strong organizational and follow-up skills, as well as attention to detail Preferred Qualifications: - Prior medical device experience preferred - Experience working in a broader enterprise/cross-division business unit model preferred - CAPA owner or a key cross-functional team member leading a CAPA project - Use of quality tools/methodologies - Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 - Risk management, post market surveillance, and manufacturing analysis Required Skills: Quality Engineering, Process Control Systems, Six Sigma, Lean Manufacturing Important Skills: FDA Regulations, ISO 13485, ISO 14971 Benefits: Free medical coverage in our Health Investment Plan (HIP) PPO medical plan, An excellent retirement savings plan with high employer contribution, Tuition reimbursement, The Freedom 2 Save student debt program, FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree