Sr. Field Assurance Associate

Posted Date 1 month ago(2/16/2018 3:47 PM)
Job ID
Job Location
# of Openings
Field Assurance


Is This The Role For You?


We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.


If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

Position Overview

Under the direction of the Field Assurance Manager, and with minimal supervision, will assist with maintaining the Field Assurance Program to ensure compliance to all safety, regulatory and corporate requirements. Ensure compliance to U.S. and international regulations regarding the handling and reporting of Customer/Product Complaints, Adverse Events, and Field Actions. Ascertain that areas identified as “Principle Responsibilities” are accomplished in an efficient and professional manner.   



  • Knowledge of all applicable standards, regulations and procedures related to the handling of Customer Complaints, Adverse Events, and Field Actions for both tissues and devices.


  • Generate Post-Market Surveillance Plans and Reports in compliance with Field Assurance procedures and regulatory requirements.


  • Generate Field Assurance Monthly Trending reports and provide internal awareness of noted trends, Adverse Events, and Complaint issues for management review.


  • Develop, implement, revise and follow procedures to ensure processes are in place for the timely and accurate receipt, logging, analysis and response to Customer/Product Complaints.


  • Assist in training/educating new Field Assurance employees.


  • Perform tasks associated with Field Actions, including identification of affected product, consignee notification, and regulatory reporting in accordance with applicable local, state, federal and international regulations.


  • Review Customer complaints for validity and ensure complaints are processed efficiently in compliance with Field Assurance procedures.


  • Perform approvals of regulatory reporting evaluations within the complaint records to ensure reporting complies with applicable local, state, federal and international regulatory reporting requirements for Complaint Handling and Adverse Event Reporting.


  • Ensure Customer Complaint investigation activities comply with applicable local, state, federal and international regulatory reporting requirements for Complaint Handling and Adverse Event Reporting.


  • Perform administrative tasks associated with Complaint investigations and documentation to ensure Complaints are accurate, comprehensive and completed in a timely manner including submissions and tracking of formal reports to regulatory bodies.



  • Conduct final review of complaint files, including but not limited to complaint summaries, coding incidents for appropriate conclusions, external/interdepartmental reports, root cause analysis, and identification of potential Corrective Actions/Preventive Actions (CAPAs).


  • Interact with Healthcare workers and CryoLife employees regarding Customer complaints and/or Adverse Events.



  • Coordinate and lead multidisciplinary teams during in-depth investigations of Adverse Events and/or Customer Complaints and where noted identify trends.


  • Provide guidance and education regarding Customer Complaint processing, Medical Device Reports, complaint reportability, complaint scenarios, sample return procedures and regulatory compliance.



  • Will maintain the Field Assurance Laboratory, including but not limited to routine cleaning, stocking supplies and equipment repair requests.


  • Bachelor’s Degree, preferably in Nursing, BioMedical Engineering, or a Life Science.


  • Minimum of 2 years’ experience in a regulated industry, preferably with knowledge of ISO, FDA and the Quality System Regulation.


  • Ability to maintain a high energy level and be able to prioritize, manage and follow up on numerous projects.


  • Effective communication skills, both oral and written, with an ability to communicate and interface with people at all levels.


  • Detailed orientated and exhibit a high degree of flexibility and initiative.


  • Personal computer skills, i.e. word processing, excel spreadsheets.


Company Info

Who We Are.


CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.


CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.


CryoLife is an Equal Opportunity/Affirmative Action employer.

CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.


Reasonable Accommodations
CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.


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