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Engineer - Complaints Investigator – Hybrid - (JP9863)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Engineer - Complaints Investigator – Hybrid - (JP9863)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: Complaints Trending
Duration: 3 years
Notes:  Onsite 50%, must be available to go onsite when needed
Posting Date:  02/25/2022

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 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 equiment 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.

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

Top Must-Have Skill Sets:
  • Experience in technical investigation and root cause analysis
  • Able to collaborate and communicate with cross functional team
  • Excellent technical writing and interpersonal skills

Day to Day Responsibilities:
  • Perform device assessments of complaints and document results in a report.
  • Perform root cause analysis investigations for mechanical and/or electromechanical products.
  • Complete evaluation and deliver assessment report on time per clienta 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.

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 team leader.

Employee Value Proposition:
The person in this role will have the opportunity to identify product defects. You will also learn to work with cross-functional teams to decrease product defect and customer complaints.

Red Flags:
Lack of basic qualifications and 3 must have skills.
  • Interview process:
    Phone screening (15-30 min with hiring manager)
  • Video call / interview with cross-functional team (4-5 members, 30 min each)
  • Phone screening can start on 2/25/2022

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.
3KC Talent Acquisition Team
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