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: Performs 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.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Performs other related duties and responsibilities, on occasion, as assigned.
Equipment: List the type of equipment the incumbent will utilize in this position.
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.
Working Conditions: Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job. Works in an air-conditioned clean-room manufacturing environment; requires gowning attire and hair/beard covers to maintain a particle free environment. Low to moderate noise level. Minor exposure to chemicals. May work at a desk or workstation.
Qualifications: Describe the minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates, license, and/or registrations required.
• High School degree/GED.
• 0-2 year's experience.
• Previous experience in Quality performing inspection.
• Prior medical device component inspection experience preferred.
• 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.
• ASQ CMI certification 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.
• Must be willing to work overtime as required, including weekends • Ability to maintain regular and predictable attendance.