Quality Systems, Regulatory Compliance Manager

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

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 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 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

Our location in Lake Forest, IL has currently an open position for Quality Systems, Regulatory Compliance Manager. This person will be responsible for quality systems and/or quality subsystems and/or key process(es). Incumbent may be a Key Process Owner for a key process(es) or provides managerial oversight, examples include but not limited to: QMS Monitoring, Nonconformance/ CAPA, and PRRC (Person Responsible for Regulator Compliance). Directs multi-site, Division-wide activities to accomplish quality system objectives and goals. The incumbent is the Subject Matter Expert and is the primary representative during internal and external inspections such as FDA, ISO, and AQR.

What You’ll Work On

• Identifies as the SME for a division quality system, quality subsystem and/or key process.
• Identifies and recruits staffing resources to support divisional scope, multi-site quality system projects.
• Manages Division-level, professional staff to achieve division goals and strategic initiatives.
• Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide.
• Primary Division contact for domestic/international sites and affiliates regarding quality systems,and/or quality subsystems and/or key processes.
• The above statements are intended to describe the general nature and level of work being performed,other duties may be performed as assigned.
• Interact frequently with Division Management with executive responsibility,and therefore requires a high level of competence,confidence and credibility.
• Strategic and tactical decisions for the Division will be made based upon the information that the individual gathers, provides and/or presents in a management setting.
  
  

Required Qualifications

• Bachelor's degree preferably in a science, technical and/or engineering discipline.
• Minimum 8 years' experience in medical device industry or other FDA regulated industry experience.
  
  

Preferred Qualifications

• Experience authoring and/or managing Nonconformance/CAPA
• Prior audit and inspection support experience
• Prior Quality System experience or Quality subsystem document owner experience
  
  

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 and @AbbottGlobal.

The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.