Quality Engineer (1)
Gi Group
Southend-On-Sea, Essex, GB
10d ago

Job Description : Quality Engineer


The Post-Market Quality Engineer works cross-functionally with quality, operations, sales, field service, and sustaining engineering to support products that have been released to the field.

This position plays a critical role for the business by investigating customer feedback and performing product performance monitoring and trending.

In this role you will conduct product performance investigations that will lead to design, manufacturing and use improvements.

This position will ensure product performance trends are distributed on a recurring basis for leadership review as part of the management review process.

Principal Responsibilities

  • Participate in the complaint handling process by leading complaint investigations
  • Apply engineering judgement and product knowledge to properly assess returned devices
  • Perform complaint investigations, including, as appropriate, decontaminate and analyze returned devices, determine root cause, identify non-
  • conformances, initiate health risk assessments, and generate reports and trends

  • Proactively work with other departments (R&D, Manufacturing, Quality, Design Assurance, Marketing, Regulatory, Field Service) to review returned devices and root causes, as necessary, to support investigations
  • Meet goals and metrics to timely and accurately complete investigations of complaints in support of medical device regulatory reporting
  • Identify high-level complaints or incidents that may have a significant impact on the business.
  • Proactively follow steps to judge escalation of high priority and / or complex product complaint investigations and corrective actions
  • Perform or arrange for testing on complaint products, as necessary
  • Support investigation into complaints of distributed devices and supplier-manufactured products / components, working with external contacts and Supplier Quality to facilitate their investigations
  • Identify and implement changes to relevant QA monitoring programs to improve effectiveness and efficiency
  • Perform data analysis to generate product performance trending reports for senior leadership review and decision-making
  • Produce and maintain documentation in accordance with applicable regulations
  • Participate in external audits and inspections as a subject matter expert on complaint investigations and returned product analysis
  • Maintain quality system process for complaint investigations
  • Ensure predicate product performance is understood and provided to new product development teams.
  • Minimum Qualifications

  • Bachelor's Degree in technical or life sciences, or engineering
  • Complaint handling experience in a regulated environment
  • 2-5 years Quality Engineer experience
  • Proficiency in MS Word, Excel, Access. Must read, write and understand English
  • Self-motivated and energetic
  • Strong interpersonal skills and ability to work / influence cross functional teams
  • Problem solving ability
  • Ability to prioritize effectively
  • Ability to multi-task in a fast-paced environment
  • Oral and written presentation skills
  • Preferred Qualifications

  • Experience with electromechanical equipment or injection molding products is a plus
  • Working knowledge of FDA GMP / GLP, Medical Device Directive, and ISO
  • ASQ Quality Engineer and / or Six Sigma Green Belt certification a plus
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