Abbott Quality Assurance Product Support Specialist III in Scarborough, Maine
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 107,000 colleagues serve people in more than 160 countries
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our location in Scarborough , Maine currently has an opportunity for a Quality Assurance Product Support Specialist III. In this role you will manage and maintain various regulatory compliance programs, as well as providing specific and advanced support as needed to other quality assurance functions and customers. This position is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities.
WHAT YOU'LL DO
Post Market Activities:
Customer Complaint Investigation Program, including 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.
Provide training and monitoring for Technical Service o Assist with continuous improvements in Complaint Handling. Monitor and trend metrics as required.
Product Recall / Field Action Activities: coordinate activities as required.
Post Market Surveillance: responsible for providing inputs and managing elements of this program as required.
Product Training: Create and maintain product training and troubleshooting materials for the product support and technical service teams. Participate in new product development programs as an SME for product support.
Participates in the internal and external audit program as an auditor and for external vendor audits as needed.
Writes, reviews and approves Standard Operating Procedures, guidance documents, and training materials as needed. Performing training events as needed.
Identify events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation.
Perform training events as needed.
EDUCATION AND EXPERIENCE YOU'LL BRING
Bachelor’s degree in Biology, Chemistry, Immunology or a related technical field or equivalent education and experience.
Proficient in the use of Database software; Internet software; Spreadsheet software and Word Processing software.
Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.
Demonstrated understanding of lab practices.
Ability to travel approx. 10% of the time.
- 5+ years of experience in Quality Assurance role in the medical device industry
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 (http://www.abbott.com/) , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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 email@example.com