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Engineer, Complaints Investigation – Hybrid - (JP10429)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Engineer, Complaints Investigations – Hybrid - (JP10429)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type:  Contract
Business Unit: Complaints Trending
Duration: 1+ years (with likely extensions)
Notes:  Only qualified candidates, please.

Posting Date:  06/09/22

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

Job Description:
Client is currently seeking an Engineer in the Complaints Trending and Investigation (CT&I) group. This position will report to Senior Engineer, Complaints Trending and Investigation. In support of client’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

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 client’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.

Basic Qualifications:
Basic Education: Bachelors Degree with 2 years of experience or Masters degree.

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 Amgen 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:
Phone screening followed by in-person interview.



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

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