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Fresenius Medical Care North America Manager, Post Market Surveillance - NxStage in Lawrence, Massachusetts

Job ID 19000E5X

Available Openings 1

Position Specific Information

NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities. 


The incumbent will provide support and direction to the execution of the complaint processes throughout the organization to monitor and analyze product performance data from a variety of internal and external sources.  


Ensures processes and systems are effective to receive, review, and investigate critical product complaints investigation. Reviews for closure various product complaints which include reportable complaints. Helps provide customer support and serves as liaison between Quality Engineering, Postmarket Investigators, and Postmarket Clinical, and sales force regarding potential product problems.


• Manage postmarket surveillance complaints intake staff

• Manage international complaints investigations, escalation, and response

• Prepare agendas, facilitates cross functional meetings to drive moderate to complex product complaint investigations and creates meeting minutes

• Work with Postmarket Surveillance and Quality Engineering personnel to ensure complaint records are accurate, complete, and follow good documentation practices

• Perform queries to provide complaint data and analysis on reported product problems/complaints

• Interface with distributors, sales force, international representatives, and in-house departments for complaint information

• Review or prepare customer communication (response letters, acknowledgement letters) as appropriate

• Drive continuous quality improvement

• Create or update QMS documents

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.


The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 



BA/BS in a life sciences field and 4 years applicable experience; or 8 years experience working directly with customers in a complaint handling capacity.



  •     Experience with Class II and Class III medical devices is desired
  •     Drug experience a plus
  •     Strong attention to detail in composing and proofing-reading materials, establishing priorities, scheduling and meeting deadlines
  •     Demonstrated ability to work in a fast-paced environment and simultaneously manage multiple competing tasks and demands
  •      Ability to work independently, take initiative and complete tasks to deadlines
  •     Decision-making capability, providing advice to the team
  •     Excellent communication skills – verbal and written.
  •     Strong analytical and data analysis skills
  •     Experience leading improvement projects
  •     Six Sigma certification a plus

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity