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 Title **Quality Assurance Manager, Instruments** 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** Our location in Scarborough, ME currently has an opportunity for **Quality Assurance Manager, Instruments** is within our Infectious Disease business unit. This opportunity will ensure successful day to day operations of the designated Quality Assurance group, which includes instrument reservicing support. **WHAT YOU’LL DO** + Responsible for managing, training and supporting the work of the Quality Assurance group in their designated responsibilities within instrument reservicing and support. + Oversees review and release of instruments for sale, ensuring compliance to regulations and Abbott policies. + Responsible for coordinating and implementing change management activities for instrument servicing. + May act as the Quality Assurance representative to author as well as review and approval for QIs and CAPAs. + Continuously improves and maintains the QMS Processes, assuring compliance to applicable standards. + Write and maintain the QMS SOPs, develop and generate relevant metrics and trending. + Responsible for providing input into the Risk Management Process. + Actively participates in product or process troubleshooting, and root cause analysis, by providing feedback and offering solutions that meet both business and compliance needs. + This position may lead or participate in site projects or corporate projects. + This position manages employees in the Quality Assurance group and carries out management and supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. **Required** **QUALIFICATIONS** + Minimum Bachelor's degree in Engineering, Chemistry, Biology, Life Science or related discipline or equivalent combination of education and experience required. + In-depth knowledge of FDA cGMPs/QSR, IVDR and ISO Quality System Requirements. + Demonstrated understanding of instrument manufacturing practices. + Knowledge of Database software; Internet software; Spreadsheet software and Word Processing software. + Ability to travel 10% of the time **PREFERRED:** + 5+ years’ experience in a medical device company in a quality or regulatory function, with management experience preferred. + Lean or Six Sigma experience preferred. 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 $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com