Senior Specialist Quality Assurance

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Senior Specialist Quality Assurance Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 you dream of. 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. The Senior Specialist, Quality Assurance role is part of our Molecular Diagnostics Business Unit and is based at either our Des Plaines, IL or Lake Forest, IL location. This role will conduct quality-related activities in the area of Complaint Handling to deliver consistent, high-quality documents, services, products, and processes that add value to the business. The primary function of the Quality Specialist is to assist in maintaining the quality system. What You’ll Work On Complaints Coordination, Postproduction Risk, CAPA, Surveillance and Maintenance, Field Actions, Metrics, etc. Assist with other support duties as assigned. Participate in the Corrective Action/Preventive Action (CAPA) process, including the investigation of failures or deviations as required. Maintain product complaint logs to identify and report recurring issues to Quality Assurance Management and Product Development. Collaborate with other internal groups to respond to product inquiries and issues. Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations. Collaborate with members of the Quality Assurance team working on special projects. Participate on permanent and temporary teams that are process- or project-driven. Become familiar with and serve as a subject matter expert on electronic support systems, including TraqWise, CMSNext, SmartSolve, SAP, and related platforms. Collect, analyze, and publish quality metrics. Assist in the preparation of distribution reports as needed for product information letters and field actions. Support the drafting of field action letters and other field action-related documentation. Reconcile and maintain field action files, ensuring all documentation is complete and appropriately filed in accordance with corporate/division standards to facilitate easy retrieval for audit support. Prepare 806 monthly status reports in support of 21 CFR Part 806 field action requirements. Track recall activities through closure and prepare final closure documentation for each field action file. Support audit readiness activities for internal (site, division, and corporate) and external (FDA, ISO, BSI, TUV, etc.) audits. Handle data requests from other departments pertaining to risk or field action data. Serve as a team member and/or leader on projects focused on continuous process improvement. May own CAPA activities for department CAPAs. Facilitate the post-production risk process in cases involving distributed nonconforming product and may support drafting post-production risk records. Required Qualifications Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience. At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Direct experience in a Quality or Regulatory Affairs role in a GMP related industry Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement. Candidate should be flexible, have strong problem-solving skills, excellent written and oral communication skills, and be able to lead cross functional teams. Preferred Qualifications Experience with post-market quality Experience participating in or supporting both internal and external audits Working knowledge of ISO 13485 (QMS), 21 CFR, IVDR 2017/746, MDR 2017/745, and other international regulations Experience with medical devices containing software Experience working with software management systems, such as ERP systems Proficient in Microsoft Office Word, Excel, and PowerPoint Must have the ability to support business needs across different time zones, as needed Excellent written and oral communication skills Strong organizational and prioritization skills Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:AMD Molecular LOCATION:United States > Des Plaines : DP01 ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Not specified MEDICAL SURVEILLANCE:Not Applicable 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), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf