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.
PURPOSE AND SCOPE:
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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
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 AND REQUIRED SKILLS:
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 andsimultaneously manage multiple competing tasks and demands
Ability to work independently, take initiative and complete tasks todeadlines
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
Fresenius Medical Care North America
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