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Engineer, Biotech Medical Device Complaints Investigator (JP10155)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer, Biotech Medical Device Complaints Investigator (JP10155)
Location: Thousand Oaks, CA 91320 (onsite)
Employment Type: Contract
Business Unit: Complaints Trending 
Duration: 3 years with possible conversion to FTE in between
Job posting date: 4/28/2022
Note: Onsite 80%

3 Key Consulting is hiring an Engineer, Complaints Investigation Technical Investigator for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will 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 root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Basic Qualifications:
Master’s degree; OR Bachelor’s degree and 2 years of related medical/biopharma

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 team leader

Top Must have Skill Sets:
  • Experience in technical investigation and root cause analysis
  • Able to collaborate and communicate with cross functional team
  • Master’s or Bachelor’s in Engineering, Science or Biomedical
  • 1-2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
  • Experience in lab environment

Day to Day Responsibilities:
  • Perform device assessments of complaints and document results in a report.
  • Complete evaluation and deliver assessment report on time per client’s 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
  • Perform characterization testing and support data gathering for investigations
  • Support root cause analysis investigations for mechanical and/or electromechanical products

Red Flags:
No engineering background or experience
Lack of basic qualifications and 3 must have skills

Interview Process:
1) Phone screen
2) Video Panel Webex interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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