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Quality Engineer II

Company: Abbott Laboratories
Location: Minnetonka
Posted on: January 13, 2022

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 109,000 colleagues serve people in more than 160 countries.Quality Engineer II - Minnetonka, MNSchedule M-FHours: 2:00 pm - 10:00 pmLeading an active lifestyle is important to the many people we serve. In Abbott's Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.-- - WHAT YOU'LL DO-- -We are recruiting for a Quality Engineer II located at in Minnetonka, MN.-- - You will assure new or modified products conform to requirements and establish compliance with the quality 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.-- - You will support new product development projects as well as support sustainability of commercially released product. You may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality. ResponsibilitiesIdentify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsLead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsAssist in the development and execution of streamlined business systems which effectively identify and resolve quality issuesApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesDesign and conduct experiments for process optimization and/or improvementAppropriately document experiment plans and results, including protocol writing and reportsLead process control and monitoring of CTQ parameters and specificationsLead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)Lead the investigation, resolution and prevention of product and process non-conformancesParticipate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)Lead in the completion and maintenance of risk analysisWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesSupport 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. EDUCATION AND EXPERIENCE YOU'LL BRING-- -Required-- -Bachelor's Degree in engineering or Technical Field or an equivalent combination of education and work experience2-5 years Engineering experience and demonstrated use of quality tools/methodologies.-- - Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Risk management, post market surveillance, and manufacturing analysisAbility to work in a highly matrixed and geographically diverse business environmentAbility to work within a team and as an individual contributor in a fast-paced, changing environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMultitasks, prioritizes, and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detailPreferred-- -Prior medical device experience preferredExperience working in a broader enterprise/cross-division business unit model preferredCAPA owner or a key cross-functional team member leading a CAPA project WHAT WE OFFER-- --- -At Abbott, you can have a good job that can grow into a great career. We offer:-- -A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit, and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistance-- --- -Financial security through competitive compensation, incentives, and retirement plans-- --- -Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs-- -Paid time off-- --- -401(k) retirement savings with a generous company match-- -The stability of a company with a record of strong financial performance and history of being actively involved in local communities-- -Learn more about our benefits that add real value to your life to help you live fully:"-- - -- --- -Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.-- -

Keywords: Abbott Laboratories, Minnetonka , Quality Engineer II, Engineering , Minnetonka, Minnesota

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