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 113,000 colleagues serve people in more than 160 countries.

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

We have an opportunity for a Quality Assurance Team Lead – Product Support within our Infectious Disease Developed Markets business unit located at Abbott Park, IL. In this position the incumbent is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities.

The QA Product Support Team Lead will be responsible for conducting and or oversite of training and competency assessment of new employees. This role will serve as a subject matter expert to Quality Assurance Product Specialists and provide guidance on consistent compliant execution of the complaint handling process. The QA Product Support Team Lead will be responsible for identifying QAPS priorities and directing QAPS team focus in response to business needs.

WHAT YOU’LL DO

• Post Market Activities:
• Oversees the Customer Complaint Investigation Program, with responsibility for deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries/conclusions.
• Maintaining effective communication with Technical Service groups (worldwide locations) regarding this site’s product complaint investigations.  Ensuring product support achieves KPIs around complaint handling.

• Serves as SME for management of high-risk complaint cases and monitoring of associated activities.
• Assists with continuous improvements in Complaint Handling.  Monitor and trend metrics as required.
• Provides training, competency assessment, and monitoring of new and existing Product Support employees.
• Writes, reviews, and approves Standard Operating Procedures, guidance documents, and training materials as needed.  
• Product Training:  Create and maintain product training and troubleshooting materials for the Product Support and Technical Service teams.
• Other duties as required.

Supervisory Responsibilities

• May supervise QA Technician, QA Specialist I and QA Specialist II day-to-day functions.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor’s Degree in Chemistry, Biology, Life Sciences, or other related technical field or the equivalent combination of education and experience.
• 5+ years of experience in Quality Assurance role in a regulated industry with preferred experience in the medical device industry.
• Proficient in the use of Database software; Internet software; Spreadsheet software and Word Processing software.
• Ability to travel approximately 10% of the time.

PREFERRED QUALIFICATIONS:

• Previous experience with medical device complaint handling and/or Technical Service.
• Experience with managing resources and team dynamic.

COMPETENCIES:

• Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.
• Demonstrated ability to analyze data and draw appropriate conclusions.
• Strong written and verbal communication skills.
• Strong leadership skills that strive for a collaborative and positive team environment.
• Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.
• Demonstrated understanding of lab practices.

WHAT WE OFFER

• At Abbott, you can have a good job that can grow into a great career. We offer:
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.