Engineer - Complaints Investigator Medical Device JP10527
Engineer - Complaints Investigator Medical Device JP10527
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Salary Not Disclosed
1 Vacancy
Job Description
Location:Thousand Oaks CA. 34 days onsite)
Employment Type: Contract
Business Unit:Complaints Trending
Duration:3 years with possible conversion to FTE
Posting Date: 7/7/2022
Target start date:8/8/2022
3 Key Consulting is hiring anEngineer Complaints Investigatorfor 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 crossfunctional 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 MustHave Skill Sets:
- Experience in technical investigation and root cause analysis
- Able to collaborate and communicate with cross functional team
- Masters or Bachelors in Engineering Science or Biomedical
- 12 years of experience in complaints investigation within a development manufacturing postmarket or equivalent environment
- Experience in lab environment
- 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
No engineering background or experience
Lack of basic qualifications and 3 must have skills
Interview process:
Phone screening 1530 min with hiring manager)
Video call / interview with crossfunctional team 34 members 30 min each)
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Employment Type
Full Time
