Quality Engineer I at Abbott in Plymouth, MN

Summary: Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Engineer I role involves supporting and maintaining quality assurance programs, ensuring that product performance and quality conform to established standards and regulations. Responsibilities: - Responsible for compliance with applicable Corporate and Divisional Policies and procedures - Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company - Prepares reports, publishes, and makes presentations to communicate findings - Analyzes and solves problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology - Understands and can apply engineering principles theories, concepts, practices, and techniques - Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company - Incorporates business policies and procedures into task completion - Cultivates internal and external network of resources to complete tasks - Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives - Supports project team, determining goals and objectives for the projects - Recommends and implements changes to the system as the result of changing regulations and/or business needs - Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction) - Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements - Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc - Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility - 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, FDA regulations, ISO 13485 Important Skills: Risk management 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