Senior Complaints and Vigilance Specialist in Elstree at Stryker Corporation

发布日期: 10/8/2019



Your key responsibilities

  • Work with all product/manufacturing/quality teams to ensure timely, accurate and complete investigations of product complaints to identify root cause leading to implementation of proper corrective actions and verifying those actions as effective.
  • Review reports of customer complaints, assess them for MDR / MDV reportability to FDA / Competent Authorities
  • Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
  • Interact with health care providers, sales representatives, patients, Regulatory Agencies regarding complaint investigations and to assure their questions are addressed within established time-frames
  • Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
  • Update current procedures/processes or create new procedures/processes
  • Generate and track metrics on process timeliness and effectiveness
  • Participate in continuous improvement and process re-engineering projects in support of continuous improvement initiatives.
  • Generate data for Competent Authorities (FDA, BSI and other regulatory bodies).
  • Actively participate in product recalls and recall communications as required.

What are we looking for?

  • BSc in Engineering, Science, or related.
  • Minimum 3 years professional experience in the Medical Device Industry; preferably in Post-Market Surveillance
  • Demonstrate applied knowledge of regulatory requirements, including MDR/MDV reporting
  • Demonstrated expertise leading failure investigations and performing Root Cause Analysis
  • Demonstrated ability to manage complex or broad scope projects
  • Demonstrated ability to deliver positive, energetic support to a team, and to be an advocate for quality
  • Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines
  • Demonstrated verbal, written and interpersonal skills. 
  • Demonstrated organizational, problem-solving, analytical and time management skills
  • Applied knowledge of Microsoft Office software including Excel, Word and Power Point.

Work From Home: No

Travel Percentage: None