Job Details
Posted 6 May, 2026
Job Id: 627698
Complaints Investigation Technical Investigator
Job Description
Target PR Range: 33-43/hr DOE
Seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr. Engineer in Complaints Trending and Investigation group. In support of mission to serve patients, the Complaints Trending and Investigation group is 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 complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner 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/leading root cause analysis.
S/he will also support the implementation, validation, and operation of the equipment in the 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.
Responsibilities:
* Perform device assessments of complaints and document results in a report.
* Complete evaluation and deliver assessment report on time per 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
* Perform root cause analysis investigations for mechanical and/or electromechanical products
Basic Qualifications
* Masters degree; OR
* Bachelors 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
* Masters or Bachelors 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
* 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
* Strong Sense of Responsibility and Time Management.
* Demonstrated competency in root cause analysis methodology
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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