Engineer - Complaints Investigator – Hybrid - (JP9863)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Laguna Niguel , Engineer - Complaints Investigator – Hybrid - (JP9863), Engineering , Thousand Oaks, California
