Post Market Surveillance Analyst II at Abbott (Dallas, TX)

| Dallas-Fort Worth, TX
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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.

JOB DESCRIPTION:

Job Description

Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson's disease and essential tremor symptoms, steering away from side effects.

Our location in Plano, TX currently has an opportunity for a Product Surveillance Analyst II. Under the direction of management, the Postmarket Surveillance Analyst II may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering).

WHAT YOU'LL DO:
  • Initiates and manages the complaint file. Maintains accurate entry of complaints in the database.
  • Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices).
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
  • Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management.•
  • Prepares customer letters with investigation findings. Is diligent of any unusual trends in product complaints and communicates them to management.
  • Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings). Archives complaint records and retrieves information on closed investigations.
  • Ensures accurate department procedures and work instructions are maintained.
  • Train new employees to the complaint handling process.
  • Provide support to the Legal Department regarding product complaints.
  • Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Performs product evaluations in a timely manner. Executes product evaluations to develop a well-documented and accurate root cause evaluation.
  • Coordinates product evaluations with other SJM departments and external consultants.
  • Interprets/reviews technical product specifications, measurements and the Device History Record.
  • Prepares technical reports of findings and enters them into the complaint system. Reviews external vendor/consultant evaluations and enters them into the complaint system.
  • Adheres to the device retention and disposal procedures. Ensures accurate department procedures and work instructions are maintained.
  • Collaborate independently with other team members and departments needing product evaluation information. Be able to ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues). Train new employees to the product evaluation process.
  • Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.


EDUCATION AND EXPERIENCE YOU'LL BRING
Required
  • Bachelor's Degree in healthcare or sciences or equivalent combination of education and work experience.
  • Strong written and oral communication skills.
  • Excellent ability to multitask, prioritize and meet deadlines.
  • Work independently and in a team in a busy department, while managing multiple on going tasks and investigations.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Experience working in a broader enterprise/cross-division business units.
  • Ability to leverage and/or engage others to accomplish projects.


Preferred
  • Knowledge of global regulations for medical device reporting and medical terminology is a plus.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
  • Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
  • 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: www.abbottbenefits.com

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.

JOB FAMILY:
Operations Quality

DIVISION:
NM Neuromodulation

LOCATION:
United States > Texas > Plano : 6600 Pinecrest

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
More Information on Abbott
Abbott operates in the Healthtech industry. The company is located in Abbot Park, IL. Abbott was founded in 2022. It has 97838 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 225 open jobs at Abbott, click here.
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