Postmarket Surveillance Analyst 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).

The other role of the Postmarket Surveillance Analyst is 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:

• Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
• Solid understanding and application of business concepts, procedures and practices.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit.

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

·        Production areas that are clean, well-lit and temperature-controlled

·        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. 

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