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Analyst I, Complaint Investigation

BD
Covington, UAE
Full Time
Entry
Onsite
4 weeks ago
Root Cause AnalysisData AnalysisTechnical DocumentationExcelGMP/GLPFDA Regulations
Free

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Position Summary

  • This role is responsible for conducting and documenting complaint investigations for BD UCC products, including laboratory testing and root cause analysis.
  • The position ensures investigations are completed accurately, efficiently, and in compliance with FDA and ISO requirements.
  • The role is onsite, enabling hands on lab work, real time collaboration, and accelerated development through direct engagement with experienced investigators and cross functional teams.

Key Responsibilities

  • Conduct end to end complaint investigations, including evaluation, testing, root cause analysis, and documentation
  • Perform laboratory testing in compliance with GMP/GLP standards
  • Analyze data and develop clear, evidence based conclusions
  • Manage complaint records to ensure accuracy, completeness, and timely closure
  • Collaborate with manufacturing sites, suppliers, and Quality teams to resolve product issues
  • Support regulatory compliance by ensuring proper complaint documentation and escalation per FDA/ISO requirements
  • Operate, maintain, and troubleshoot laboratory equipment and testing instruments
  • Communicate investigation findings to cross functional stakeholders
  • Contribute to continuous improvement initiatives and team problem solving efforts

Required Qualifications

  • Bachelor's degree in Science, Engineering, or related field
  • 1–3 years of experience in a regulated environment (medical device, pharma, or similar)
  • Exposure to complaint handling, investigations, or quality systems
  • Basic knowledge of FDA and ISO requirements
  • Experience with data analysis and technical documentation
  • Proficiency in Excel (pivot tables, VLOOKUP)
  • Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

Preferred Qualifications

  • Hands on laboratory testing experience
  • Experience with root cause analysis and complaint investigations
  • ASQ certification (CQE, CQA, etc.)

Key Skills

  • Strong analytical and problem solving ability
  • Attention to detail and documentation accuracy
  • Technical writing and communication skills
  • Ability to manage multiple investigations and deadlines
  • Collaborative mindset with ability to work cross functionally

Physical Demands

  • While performing the duties of this position, the employee is regularly required to sit, stand, walk, and communicate effectively, including talking and listening.
  • The role involves periodic movement within a laboratory or production environment to support testing, investigations, and collaboration activities.
  • Specific vision abilities required include close vision, color vision, and the ability to focus on detailed work such as sample evaluation and data analysis.
  • The employee may occasionally be required to lift and/or move items weighing up to 25 pounds.
  • Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the role.

Work Environment

  • The work environment for this position is primarily office and laboratory setting with generally quiet to moderate noise levels.
  • The role involves minimal exposure to manufacturing environments, which may include occasional noise, slight temperature variations, and limited exposure to chemical fumes under controlled conditions.
  • The position requires the safe operation, handling, and maintenance of laboratory testing equipment and measurement instruments, in accordance with established safety and regulatory standards.

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