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Complaints Investigation Technical Investigator
Complaints Investigation Technical InvestigatorPlanet Pharma • Thousand Oaks, CA, US
Complaints Investigation Technical Investigator

Complaints Investigation Technical Investigator

Planet Pharma • Thousand Oaks, CA, US
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Complaints Investigation Technical Investigator

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Job Description

Target PR Range : 30-40 / hr

The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. They will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional teams as required. They will ensure the validity and integrity of the evaluation reports and maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting / leading root cause analysis.

The investigator will also support the implementation, validation, and operation of the equipment in the lab, provide personnel training on the use of the equipment, develop and update equipment procedures, participate in the monthly lab safety inspection, and identify and report equipment repairs or maintenance. They will work with vendors to resolve issues and suggest improvements related to equipment operation.

Responsibilities

  • Perform device assessments of complaints and document results in a report.
  • Complete evaluation and deliver assessment reports on time per requirements.
  • Support the implementation and management of the lab infrastructure, including all equipment used for investigations
  • Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
  • Support characterization testing and data gathering for investigations
  • Perform root cause analysis investigations for mechanical and / or electromechanical products

Basic Qualifications

  • Master's degree; OR
  • Bachelor's degree and 2 years of related medical / biopharma development or Operations experience; OR
  • Associate degree and 6 years of related medical / biopharma development or Operations experience.
  • Preferred Qualifications

  • Master's or Bachelor's in Engineering, Science or Biomedical
  • 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
  • Experience in lab environment
  • Demonstrated competency in root cause analysis methodology
  • Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
  • Strong technical writing and interpersonal skills
  • Results-driven and detail-oriented
  • Strong Sense of Responsibility and Time Management.
  • The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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    Investigator • Thousand Oaks, CA, US

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