Specialist Quality Assurance

JOB DESCRIPTION: Job Title Specialist Quality Assurance Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career of which you dream. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. THE OPPORTUNITY We currently have an opening for an Specialist Quality Assurance for the Vascular division. This role is located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Supports in the selection, approval and maintenance of Division’s approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. Ensures that the Division Approved Supplier List is maintained and accurate. Assess potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desktop audits, and review of other objective evidence, as required. Communicates Division approval requirements to supplier and monitors feedback per project timelines. Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings. Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab. Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues. Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action. Monitors supplier performance and reports supplier quality trend data. Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program. Responsible for approving First Article Inspections and/or Golden Samples, as initiated by suppliers. Assists with the evaluation and approval of supplier requested changes or improvements. EDUCATION AND EXPERIENCE YOU’LL BRING Minimum Education Bachelor’s Degree in Science or Engineering disciplines preferred or an equivalent combination of education and work experience Required Qualifications 2 years related work experience Supplier Quality experience in the medical device or pharmaceutical, or other quality managed industries. Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, & IVDD. Well developed written, oral and interpersonal skills. $61,300.00 – $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: AVD Vascular LOCATION: United States > Minnesota > St. Paul : 1225 Old Highway 8 NW WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Abbott is an Equal Opportunity Employer, committed to employee diversity. EEO is the Law link - English: EEO is the Law link - Espanol: #J-18808-Ljbffr