Post Market Surveillance Analyst - 27368BR - EN in Allendale, NJ at Stryker Corporation

Date Posted: 4/16/2018

Job Snapshot

Job Description

Lead and manage the complaint intake process from inception to closure. Work closely with complainants including sales reps, patients and surgeons and with the complaint investigators.
  • Complaint Intake/Closure
  • Lead and manage the complaint intake process
  • Provide training & counseling to in-house and field employees in maintaining compliance related to the complaint handling process and related activities
  • Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint submission
  • Identify solutions and opportunities for improvement and provide potential solutions
  • Develop, implement, and maintain department procedures and work instructions
  • Receives and evaluates US-based product complaints and performs entry into the electronic complaint handling system (Trackwise)
  • Communicate with sales reps & field personnel in order to obtain the information required to complete complaint investigations
  • Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint to the final closure
  • Close completed complaint investigations and review investigations to ensure thoroughness
  • Working closely with legal dept. in preparing responses to customer inquiries regarding complaint investigations
  • Send Salesperson closure letters when requested
  • Return Product Logistics
  • Manage and lead the product return process for complaint-related products
  • Assist in identifying and analyzing the Training needs of designated functional areas as needed
  • Miscellaneous
  • Administer eCHS access rights and permissions

Job Requirements

  • 4 year degree
  • 2-5 years’ experience, preferably in FDA regulated environment
  • Adaptable to a fast paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamically thriving environment
  • Detailed-oriented—committed to accuracy, efficiency, and consistency
  • Able to work independently or with a team
  • Strong interpersonal, written and oral communication skills
  • Proven ability to communicate with Salespersons and other key field personnel
  • Good time and project management skills with the ability to multi-task
  • Strong leadership skills
Spinal/Orthopedic product knowledge desirable

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