Engineer - Complaints Investigator, Medical Device (JP10324)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
|
|
|
Job Description:
Job Title: Engineer - Complaints Investigator, Medical Device
(JP10324) Location: Thousand Oaks, CA. (3-4 days onsite) Employment
Type: Contract Business Unit: Complaints Trending Duration: 3 years
with possible conversion to FTE Posting Date: 5/23/2022 Target
start date: 6/27/2022 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 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. Why is the Position Open? Staff
Augmentation 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. Perform root cause
analysis investigations for mechanical and/or electromechanical
products Complete evaluation and deliver assessment report on time
per Amgen 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 Red Flags: No engineering background or experience
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 (3-4 members, 30 min each)
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. Regards, 3KC
Talent Acquisition Team
Keywords: 3 Key Consulting, Santa Clarita , Engineer - Complaints Investigator, Medical Device (JP10324), Engineering , Thousand Oaks, California
