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 109,000 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.

Abbott Rapid Diagnostics is part of Abbott’s 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.

The position of Senior QA Product Support Specialist is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will manage and maintain various regulatory compliance programs, as well as provide support as needed to other quality assurance functions. 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.

-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.

PREFERRED QUALIFICATIONS

• 5+ years of experience in Quality Assurance role in the medical device industry.

COMPETENCIES

• Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.
• Demonstrated ability to analyze data and draw appropriate conclusions.
• Strong communication skills.

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.