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James Cassidy
Life Science

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Other similar job titles you may be intertested in include: Senior Quality Engineer Lead Quality Engineer QA Engineer Design Assurance Quality Systems Engineer Supplier Quality Engineer

Please view a sample career profile in the box below
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Customer Complaints Career Profile

Customer Complaints


Customer Complaints act as the primary contact for Surgical Customers and Sales Representatives registering confidential complaints and/or product dissatisfaction and will receive, answer and document customer complaints, telephone or written, on all products and enter complaint information as required into an electronic complaint handling system and ensure our client is positioned at all times as a key preferred supplier within the medical devices space.

Role/Responsibilities

  • Receive and log product complaints from a variety of sources
  • Document and coordinate the investigation of product performance issues within EMEA
  • Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
  • Provide support on failure evaluation of returned products
  • Follow up on outstanding evaluations to ensure timeliness and regulatory compliance
  • Under limited supervision draft responses to specific product complaint and vigilance report queries from Competent Authorities
  • Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected
  • Maintain complaint tracking system
  • Prepare complaint trending reports
  • attend/facilitate meetings to resolve Customer Complaints
  • Ensure effective CAPA is taken to help prevent reoccurrence
  • Responsible for supporting field actions and other post market compliance issues as assigned
  • Provide support for the risk management process and provision of complaint data to risk management groups
  • Support other activities in the post-market surveillance system as it develops

Skills/Experience

  • Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment
  • 2/3 years experience in vigilance reporting - essential
  • Excellent technical writing experience within a medical device environment - essential
  • Good knowledge of the Medical Device Directive and familiarity with its transposition into national legislations within Europe as it affects complaint management
  • Good working knowledge of the Quality System Regulations as they pertain to customer complaints
  • Experience with bio-hazard management/contamination control preferred
  • Attention to detail and accuracy - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
  • Excellent analytical ability
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously and the ability to interface with all levels of management.