Quality Engineer I

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

We are seeking a Quality Engineer I to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing and distribution.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

• Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Coach, and mentor non-exempt personnel
• 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
• Appropriately develop and document Quality plans and reports
• Assist is the implementation of 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)
• Assist in the completion and maintenance of risk analysis
• 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
• Performs other related duties and responsibilities, on occasion, as assigned

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

• Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
• 0-3 years experience
• Solid communication and interpersonal skills
• Advanced computer skills, including statistical/data analysis and report writing skills
• 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
• Ability to leverage and/or engage others to accomplish projects
• 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
• Ability to travel approximately 5%
• Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

• Knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Engineering experience and demonstrated use of Quality tools/methodologies preferred
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Prior medical device experience preferred
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• ASQ CQE or other certifications preferred
• SAP system experience
• Distribution experience

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