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.

JOB DESCRIPTION:

Leading an active lifestyle is important to the many people we serve. In Abbott's Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

Our location in Plymouth, MN is looking for a Postmarket Surveillance Analyst II. This role focuses on performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other SJM departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment.

Job Duties:.

Duties associated with complaint investigation:

• 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)
• 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
• Support all Company initiatives as identified by management and in support of 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
• 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

• Postmarket Surveillance Analyst (product evaluations):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
• Use procedures, judgement and experience to determine appropriate testing of returned products with minimal guidance
• Reviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations)
• 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
• Maintains work area in clean and orderly condition and adheres to safety and biohazard procedures
• Is diligent of any unusual trends in product evaluations and informs management
• Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings
• 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)
• 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

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• 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

Qualifications:

• Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work
• Knowledge of global regulations for medical device reporting and medical terminology is a plus
• Strong written and oral communication skills are required
• Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
• Good problem-solving and proficient computer skills are required
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
• Ability to maintain regular and predictable attendance.

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: 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:
EP Electrophysiology

LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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