Quality Engineer I at Abbott in United States - Minnesota - Plymouth

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 assure that new or modified products conform to requirements and establish compliance with the quality system, while supporting new product development and manufacturing processes. 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 - Lead 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 - 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 non-conformances - 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 - Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities - Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements - Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors 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 Management Systems, CAPA, FDA regulations Important Skills: Six Sigma, Lean Manufacturing, Risk management Nice-to-Have Skills: communication, Team collaboration, Attention to detail, Organizational skills Benefits: Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year, An excellent retirement savings plan with high employer contribution, Tuition reimbursement, The Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree