Senior Specialist, Product Surveillance

at  Abbott Laboratories

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.

REQUIRED QUALIFICATIONS:

• Education Level: Bachelors Degree (+_ 16 years)
• Experience: Minimum 4 years – In related clinical discipline, Registered Nurse (RN)

PREFERRED QUALIFICATIONS:

• Registered Nurse (RN)
• Critical care and or cardiac care background.
• Heart Failure background
• Device experience: i.e. LVAD, Cmag, CMEMs
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups; ability to work cross-functionally. Demonstrated initiative and problem-solving skills and critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software. Ability to prioritize.
• Strong organizational and project management skills. Ability or aptitude to lead without direct authority.
• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
  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 $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted

MAIN PURPOSE OF ROLE

• Individual contributor with comprehensive knowledge in the specific area.
• Ability to execute highly complex or specialized projects.
• Adapts precedent and may make significant departures from traditional approaches to develop solutions.
• Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

MAIN RESPONSIBILITIES

• Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.
• Applies clinical knowledge and experience to guide and augment appropriateness of clinical events that impact reportability.
• Applies clinical knowledge and experience to support staff as clinical resource.
• Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Document quality issues and performance measures for management review.
• May liaise with external vendors.
• Travel up to 10% of the time both domestically and internationally by any means necessary for initial product training and to support organizational goals *CMEMS position.
• Drives functional performance that ensures cross-functional standards and expectations are met.