Instrument Quality Engineer

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. JOB DESCRIPTION: Instrument Quality Engineer 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. Youll 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 bachelors 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 Abbott Rapid Diagnostics is part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. Instrument Quality Engineer Location: South Portland, ME Business Unit: Infectious Disease Developed Markets About the Role Join our team as an Instrument Quality Engineer and play a key role in maintaining and improving our quality system. This position offers an opportunity to work on critical processes that ensure product excellence and compliance. What Youll Do In this role, you will assist with the administration of, and ensure compliance in maintaining the quality system and may be responsible for one or more of the following processes: Batch Release Complaint Coordination Metric Maintenance Surveillance Program Testing Program Document Control Exception Report and CAPA System Batch and Sample Retention and Maintenance What You'll Work On Actively monitor Third-Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory requirements (cGMP, ISO). Review GMP-related documentation for compliance, including batch records and associated manufacturing, testing, and release data; validation protocols and reports; labels; product specifications; and additional documentation as required. Participate in the Corrective Action/Preventive Action (CAPA) process, including investigations of failures or deviations in the Manufacturing area, as needed. Maintain product complaint logs to identify and report recurring issues to Quality Assurance management and product development. Collaborate with internal teams to address 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 on special projects. Participate on permanent and temporary process- or project-driven teams. Develop familiarity and subject matter expertise in electronic support systems such as TraqWise, GQMS, Team Center, Compliance Wire. Collect, analyze, and publish quality metrics. Provide data to support budgetary submissions. Assist with other support duties as assigned. Required Qualifications Bachelor's Degree in Engineering, Healthcare or Life Science. Direct experience in a Quality or Regulatory Affairs role in a GMP related industry. 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 $61,300.00 $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ID Infectious Disease LOCATION: United States > South Portland : 65 Gannett Drive 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter