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Engineer - Complaints Investigator, Medical Device (JP10245)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer - Complaints Investigator, Medical Device (JP10245)
Location: Thousand Oaks, CA. (2-3 days onsite)
Employment Type:  Contract
Business Unit: Complaints Trending
Duration: 12 months with likely extension or conversion to FTE
Posting Date:  5/16/2022

Target start date: 6/6/2022

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

Job Description:

The Engineer conducts technical investigations of complaints associated with product design and/or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of company’s packaged and/or distributed mechanical and/or electromechanical product as well as manufacturing processes for these products.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner/SEM material analysis/Instron testing machines. S/he will be responsible for authoring the device 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 assessment reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Responsibilities may also include helping with the implementation, validation of equipment in the CT&I lab, personnel training, developing and updating equipment procedures and method development/validation.

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Experience with medical devices
  • Possess strong technical writing skills\
  • Possess technical depth, detail-oriented, effective communicator
  • Experience leading root cause analysis or investigation

Day to Day Responsibilities:
  • Perform root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices
  • Perform device assessments of complaints and document results in a report.
  • Complete evaluation and deliver device assessment report on time per company requirements.
  • Support implementation and validation of equipment in the CT&I lab, personnel training, developing and updating equipment procedures and method development/validation

Employee Value Proposition:
The person in this role will learn how to perform and lead a RCA investigations and equipment validation in the lab.

Red Flags:
A history of changing jobs too frequently

Unable to work onsite
Lacking biopharma o medical device experience

Interview process:
1) Phone screen
2) 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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