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 Summary: Perform inspection and testing of purchased materials, components and products in accordance with policy and procedures.
Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. • Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. • Records inspection and test data as prescribed by written instructions and procedures. • Operates all associated test and measurement equipment as instructed and as documented in procedures. • Recommends changes to policies and procedures. • May prepare and submit change requests. • Documents non-conformances in Non-Conforming Material Review system. • Participates in GR&R studies as directed by engineers or technicians. • Collects data for First Article inspections. • Performs testing and inspection in accordance with special test requests. • May train other Inspectors. • Assists in gathering, analyzing, and trending of data. • Performs work of a miscellaneous nature as required. • 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 • 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.
Equipment: May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
Note: The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and requirements, which may change from time to time based on business needs. This job description supersedes any previous job descriptions with the same or similar title. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, national origin, marital status, age, citizenship, protected veteran status, sexual orientation, gender identity and/or gender expression, status with respect to public assistance, or disability status.
Working Conditions: Working environment varies from standard office/cubicle with air/sound/light control to general laboratory and production areas with varying physical conditions including “clean room” situations.
• High School degree/GED 2-5 years experience.
• Previous experience in Quality performing inspection.
• Previous experience working with Vision system.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing
• Training in blueprint reading and experience with inspection sampling techniques Knowledge of FDA, GMP, ISO 13485.
• Good communication and computer skills, including Microsoft Word and Excel.
• Prior medical device component inspection experience preferred.
• ASQ CMI certification.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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 maintain regular and predictable attendance; must be willing to work overtime, including weekends.