Abbott
Quality Technician II
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 114,000 colleagues serve people in more than 160 countries. This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott's Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Responsibilities Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact. Reviews and verifies compliance of documentation such as batch records, reports of nonconforming materials, inspection records. Notifies supervision of issues or errors, providing immediate response. Executes Testing of samples as part of its daily activities with minor guidance from Quality Supervisor or Quality Engineer. Identifies and segregates nonconforming material from the production line according to governing documents. Coordinates with the Quality Engineer to prepare and handle the material in and out of the designated quarantine area. Inputs data to required systems. SAP, Windchill and EPIQ to run limited queries and/or input lots, test data. 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. Qualifications Required H.S. diploma, equivalent or at least 2 years of experience as a QA Technician I or areas related to quality control. (an equivalent combination of education and work experience) Experience at medical devices companies or equivalent Applies acquired knowledge of procedures and practices and a complete understanding of fundamentals in a functional area and working knowledge of other related disciplines. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Some Microsoft Office - Handles MS Word, Power Point and Excel at a basic to intermediate level Some Basic math knowledge- Basic Math calculations 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 Prior medical device experience preferred. The base pay for this position is $19.15
$38.35 per hour. In specific locations, the pay range may vary from the range posted.
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 114,000 colleagues serve people in more than 160 countries. This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott's Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Responsibilities Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact. Reviews and verifies compliance of documentation such as batch records, reports of nonconforming materials, inspection records. Notifies supervision of issues or errors, providing immediate response. Executes Testing of samples as part of its daily activities with minor guidance from Quality Supervisor or Quality Engineer. Identifies and segregates nonconforming material from the production line according to governing documents. Coordinates with the Quality Engineer to prepare and handle the material in and out of the designated quarantine area. Inputs data to required systems. SAP, Windchill and EPIQ to run limited queries and/or input lots, test data. 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. Qualifications Required H.S. diploma, equivalent or at least 2 years of experience as a QA Technician I or areas related to quality control. (an equivalent combination of education and work experience) Experience at medical devices companies or equivalent Applies acquired knowledge of procedures and practices and a complete understanding of fundamentals in a functional area and working knowledge of other related disciplines. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Some Microsoft Office - Handles MS Word, Power Point and Excel at a basic to intermediate level Some Basic math knowledge- Basic Math calculations 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 Prior medical device experience preferred. The base pay for this position is $19.15
$38.35 per hour. In specific locations, the pay range may vary from the range posted.